Clinical trial NCT02859415
Conditions: Esophageal Neoplasms Lung Neoplasms Mesothelioma Thymus Neoplasms Neoplasms, Germ Cell and Embryonal
Keywords: Metastatic Colorectal Cancer Sarcoma ABCB4 Liver Toxicity ABCB11 Hepatotoxicity Metastatic Renal Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2019-08-08; Completion date: 2021-12-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
Background:

Mithramycin is a new cancer drug. In another study, people with chest cancer took the drug 6 hours a day for 7 straight days. Many of them had liver damage as a side effect. It was discovered that only people with certain genes got this side effect. Researchers want to test mithramycin in people who do not have those certain genes.

Objectives:

To find the highest safe dose of mithramycin that can be given to people with chest cancer who have certain genes over 24 hours instead of spread out over a longer period of time. To see if mithramycin given as a 24-hour infusion shrinks tumors.

Eligibility:

People ages 18 and older who have chest cancer that is not shrinking with known therapies, and whose genes will limit the chance of liver damage from mithramycin

Design:

Participants will be screened with:

* Medical history
* Physical exam
* Blood and urine tests
* Lung and heart function tests
* X-rays or scans of their tumor
* Liver ultrasound
* Tumor biopsy
* Participants will be admitted to the hospital overnight. A small plastic tube (catheter) will be inserted in the arm or chest. They will get mithramycin through the catheter over about 24 hours.
* If they do not have bad side effects or their cancer does not worsen, they can repeat the treatment every 14 days.
* Participants will have multiple visits for each treatment cycle. These include repeats of certain screening tests.
* After stopping treatment, participants will have weekly visits until they recover from any side effects.

Detailed description:
Background:

Increasing evidence indicates that activation of stem cell gene expression is a common mechanism by which environmental carcinogens mediate initiation and progression of thoracic malignancies. Similar mechanisms appear to contribute to extra-thoracic malignancies that metastasize to the chest. Utilization of pharmacologic agents, which target gene regulatory networks mediating "stemness" may be novel strategies for treatment of these neoplasms. Recent studies performed in the Thoracic Epigenetics

Laboratory, National Cancer Institute (NCI), demonstrate that under exposure conditions potentially achievable in clinical settings, mithramycin diminishes stem cell gene expression and markedly inhibits growth of lung and esophageal cancer and malignant pleural mesothelioma (MPM) cells in vitro and in vivo. These findings add to other recent preclinical studies demonstrating impressive anti-tumor activity of mithramycin in epithelial malignancies and sarcomas that frequently metastasize to the thorax.

Primary Objectives:

* Phase I component: To determine pharmacokinetics, toxicities, and maximum tolerated dose (MTD) of mithramycin administered as a continuous 24h infusion in patients with primary thoracic malignancies or carcinomas, sarcomas or germ cell tumors metastatic to the chest.
* Phase II component: To determine objective response rates (Complete Response (CR) + Partial Response (PR) of mithramycin administered as 24h intravenous infusions in patients with primary thoracic malignancies or carcinomas, sarcomas or germ cell tumors metastatic to the chest.

Eligibility:

* Patients with measurable inoperable, histologically confirmed lung and esophageal carcinomas, thymic neoplasms, germ cell tumors, malignant pleural mesotheliomas or chest wall sarcomas, as well as patients with gastric, colorectal or renal cancers and sarcomas metastatic to the thorax are eligible.
* Patients with favorable germline single nucleotide polymorphisms (SNPs) in ATP Binding Cassette Subfamily B Member 4 (ABCB4), ATP Binding Cassette Subfamily B Member 11 (ABCB11), Ral binding protein (RALBP) or Cytochrome P450 Family 8 Subfamily B Member 1 (CYP8B1) that are associated with resistance to mithramycin-induced hepatotoxicity.
* Patients must have had or refused first-line standard therapy for their malignancies.
* Patients must be 18 years or older with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2, without evidence of unstable or decompensated myocardial disease. Patients must have adequate pulmonary reserve evidenced by forced expiratory volume (FEV1) and diffusing capacity for carbon monoxide (DLCO) equal to or greater than 30% predicted; Oxygen saturation \>= 92% on room air. ABG will be drawn if clinically indicated.
* Patients must have a platelet count greater than or equal to 100,000, an absolute neutrophil count (ANC) equal to or greater than 1500 without transfusion or cytokine support, a normal prothrombin time (PT)/partial thromboplastin time (PTT), and adequate hepatic function as evidenced by a total bilirubin of \< 1.5 x upper limits of normal (ULN) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \<= 3 X ULN.
* Serum creatinine within normal institutional limits or creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal.

Design:

* Single arm Phase I dose escalation to define pharmacokinetics, toxicities and maximum tolerated dose (MTD).
* Patient cohorts will receive 24hour(h) infusions of mithramycin targeting total doses previously administered during 7 daily six hour infusions at 30-50 mcg/kg.
* The 24h infusions will be administered every 14 days (1 cycle). Four cycles will constitute one course of therapy.
* Pharmacokinetics and toxicity assessment to define MTD will be assessed during Cycle 1 of the first course of therapy.
* Due to uncertainties regarding potential cumulative toxicities, no intra-patient dose escalation will be allowed.
* Once MTD has been defined, patients will be enrolled into two cohorts (primary thoracic malignancy vs neoplasm of non-thoracic origin metastatic to the chest) to determine clinical response rates at the MTD, using a Simon Optimal Two Stage Design for Phase II Clinical Trials targeting an objective response rate (Response Evaluation Criteria in Solid Tumors (RECIST) of 30%.
* Following each course of therapy, patients will undergo restaging studies. Patients exhibiting objective response to therapy or stable disease by RECIST criteria will be offered an additional course of therapy.
* Patients exhibiting disease progression will be removed from study.
* Biopsies of index lesions will be obtained at baseline and on Day 4 of the first cycle of therapy for analysis of pharmacodynamic endpoints. Optional tumor biopsies may be requested at the completion of Course 1 (4 cycles) and in patients exhibiting objective responses.

Arms: arm 1: Escalating doses of Mithramycin arm 2: Mithramycin administered at MTD
Interventions: intervention 1: Mithramycin
Intervention descriptions: intervention 1: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses; Phase 2: 24 hour intravenous infusion of mithramycin given once every 14 days at MTD established in phase 1

Protocol documents:
Prot_SAP_000.pdf: 
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ICF_001.pdf: 
PATIENT IDENTIFICATION
Consent to Participate in a Clinical Research Study
NIH-2977 (4-17)
File in Section 4: Protocol Consent (1)
Version Date: 12/22/2020 
Page 1 of 13
CC ICF template v. 09.27.19
MEDICAL RECORD
CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY
PRINCIPAL INVESTIGATOR:  David S. Schrump, MD 
STUDY TITLE:
Phase I/II Evaluation of Continuous 24h Intravenous 
Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell 
Signaling, in Patients with Primary Thoracic Malignancies 
or Carcinomas, Sarcomas or Germ Cell Neoplasms with 
Pleuropulmonary Metastases
STUDY SITE: 
NIH Clinical Center
Cohort: 
Affected Patient 
Consent Version:  
12/22/2020 
WHO DO YOU CONTACT ABOUT THIS STUDY? 
David S. Schrump, MD, by phone at 240-760-6239 or email at schrumpd@mail.nih.gov 
This consent form describes a research study and is designed to help you decide if you would like 
to be a part of the research study.  
You are being asked to take part in a research study at the National Institutes of Health (NIH). 
Members of the study team will talk with you about the information described in this document. 
Some people have personal, religious, or ethical beliefs that may limit the kinds of medical or 
research treatments they would want to receive (such as blood transfusions). Take the time needed 
to ask any questions and discuss this study with NIH staff, and with your family, friends, and 
personal health care providers. Taking part in research at the NIH is your choice.
If the individual being asked to participate in this research study is not able to give consent to be 
in this study, you are being asked to give permission for this person as their decision-maker. The 
term “you” refers to you as the decision-maker and/or the individual being asked to participate in 
this research, throughout the remainder of this document. 
IT IS YOUR CHOICE TO TAKE PART IN THE STUDY
You may choose not to take part in this study for any reason. If you join this study, you may change 
your mind and stop participating in the study at any time and for any reason. In either case, you 
will not lose any benefits to which you are otherwise entitled. However, to be seen at the NIH, you 
must be taking part in a study or are being considered for a study. If you do choose to leave the 
study, please inform your study team to ensure a safe withdrawal from the research.  
WHY IS THIS STUDY BEING DONE?
The purpose of this study is to find the highest safe dose of an experimental agent, called 
mithramycin that can be given to patients with tumors in the lungs, esophagus, pleura or 
mediastinum who have a certain genetic profile over a period of 24 hours instead of spread out 
over a longer period of time. Once we determine the highest safe dose, it will be tested on 
IRB NUMBER: 16C0152
IRB APPROVAL DATE: 12/29/2020


PATIENT IDENTIFICATION
Consent to Participate in a Clinical Research Study
NIH-2977 (4-17)
File in Section 4: Protocol Consent (1)
Version Date: 12/22/2020 
Page 2 of 13
CC ICF template v. 09.27.19
MEDICAL RECORD
CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY
additional subjects with these diseases to help us determine whether mithramycin delivered as a 
24 hour infusion can cause tumors in lungs, esophagus, pleura, or mediastinum to shrink.  
Mithramycin is drug which was tested and approved as an anti-cancer therapy in the 1960’s and 
was found to have activity (shrink some tumors) against some forms of cancer. It was approved, 
but was never broadly accepted as a treatment due to serious side effects.  Mithramycin is 
considered experimental in this study because it has not been approved by the US Food and Drug 
Administration (FDA) for treatment of your type of cancer.  Because of its prior activity, 
researchers have continued laboratory research on the ability of mithramycin to fight specific 
cancers.  In the laboratory mithramycin is active against cancers of the chest, including lung and 
esophageal cancer and mesothelioma.
During a recent study of mithramycin at the NCI, subjects with the diseases under study received 
mithramycin for 6 hours a day for 7 days in a row. In this study, we discovered that many patients 
were unable to receive higher doses of mithramycin because of a side effect of liver damage. 
Further investigation revealed that only subjects that possessed certain forms of genes suffered the 
liver related side effects. Therefore, we are limiting the persons who can enroll on this study to 
those who do not possess the genes that are associated with liver side-effects.
Please note that in the current study, patients continued to experience temporary, reversible liver 
damage at the first dose we explored.  Therefore, we have lowered all of the doses we plan to test 
on this study.
WHY ARE YOU BEING ASKED TO TAKE PART IN THIS STUDY?
You are being asked to take part in this study because you have a cancer that affects the organs in 
your chest that is not shrinking with known effective therapies. In addition, you have certain 
genetic characteristics that will limit the chance that you will develop liver damage from 
mithramycin while on this study. 
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? 
Up to 60 persons will take part in this study.
DESCRIPTION OF RESEARCH STUDY
Before you begin the study
Before you begin this study, we will review your medical records and imaging studies to determine 
if you are eligible for this study. We will ask you questions over the telephone, other NIH approved 
remote platforms or in person about your medical history. 
You will need to have certain studies done in order to determine whether you meet the criteria to 
participate in this study. Any tests or procedures done specifically to evaluate if you are eligible 
for this study will be explained to you by your doctor under a separate protocol (06C0014, 
“Prospective Evaluation of Genetic and Epigenetic Alterations in Patients with Thoracic 
Malignancies”).
A pregnancy test will also be performed if you are a female who is capable of having children.
You will not be allowed to participate if we find that you are not eligible.
IRB NUMBER: 16C0152
IRB APPROVAL DATE: 12/29/2020


PATIENT IDENTIFICATION
Consent to Participate in a Clinical Research Study
NIH-2977 (4-17)
File in Section 4: Protocol Consent (1)
Version Date: 12/22/2020 
Page 3 of 13
CC ICF template v. 09.27.19
MEDICAL RECORD
CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY
During the study
Prior to Starting Treatment
Prior to starting treatment, you may have the following tests and/or procedures in order for us to 
determine the extent of your disease right before your study treatment begins:

A medical history

Physical exam including vital signs

Routine blood and urine tests

Pregnancy test (if you are a woman who could have children)

Tests that check the function of your lungs called PFTs (if necessary)

CT, PET/CT and brain MRI scans 

An ultrasound study of your liver

Research labs (~3 tablespoons) 

A tissue biopsy (if enough tissue was not able to be obtained from an earlier 
surgery or biopsy you may have had) 
Study Therapy
If the exams, tests and procedures show that you can be in the study, and you choose to take part, 
you will be admitted to the hospital at NIH and given mithramycin intravenously (IV) over about 
24 hours.  IV drugs on this study will be given through a “central line”, a catheter (or tube) that is 
surgically inserted into one of the main blood vessels in the arm or in your chest leading to your 
heart. The catheter may be tunneled under your skin and come out of your skin through a second 
small incision. We usually remove the catheter after each cycle but on occasion it can be left in for 
several cycles.
If you do not have unacceptable side effects or worsening of your cancer, this treatment can be 
repeated every 14 days.  This is called a cycle. You will have to stay overnight in the hospital for 
each infusion.
The first 3 patients on this study were enrolled in the first part of the study (Phase 1), but had side 
effects we consider unacceptable. Therefore, the dose at which the next group of 3-6 patients 
enrolled will be reduced. If that dose is found to be tolerable, we will continue to test increasing 
doses until a dose is reached at which 2 or more patients have an intolerable side effect. We will 
select the next lower dose at which no more than 1 person out of 6 has intolerable side effects as 
the maximum tolerated dose (MTD). If we reach the highest dose level we plan to test with no 
more than one patient in each of the prior dose levels experiencing intolerable side effects, the 
highest planned dose will be named the MTD once 6 subjects have been treated at that level with 
no more than 1 having intolerable side effects.
The second part of the study (Phase 2) will begin after an MTD has been determined. Every patient 
enrolling in the second part of the study will receive the study drug at the MTD.
Safety and Treatment Evaluation Assessments
While you are receiving cycles of mithramycin, you will be watched closely for any adverse 
effects.  You will need to have the following procedures and tests:

Physical exam prior to receiving study drug in each cycle.
IRB NUMBER: 16C0152
IRB APPROVAL DATE: 12/29/2020


PATIENT IDENTIFICATION
Consent to Participate in a Clinical Research Study
NIH-2977 (4-17)
File in Section 4: Protocol Consent (1)
Version Date: 12/22/2020 
Page 4 of 13
CC ICF template v. 09.27.19
MEDICAL RECORD
CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY

Blood tests daily on the first 5 days and twice in the second week for the first cycle 
(less often for subsequent cycles). 

EKG on Days 1-5 of the first cycle (Days 1 and 2 for subsequent cycles).

Scans to evaluate your tumor, described in the section titled “Research Assessments” 
below.
Research Assessments
Pharmacokinetic Studies (PKs) 
Blood samples will be obtained from you to see how much of the mithramycin is in your blood 
(pharmacokinetics).  These samples are about ½ teaspoon of blood each (~1/2 tablespoon total) 
and will be taken in Cycles 1 and 2 before the drug begins and near the end of the infusion. In 
Cycle 1 only, additional samples (~2 tablespoons total) will be taken at 2, 8 and 16 hours during 
the infusion and up to 8 samples will be taken periodically for up to 12 hours after the infusion has 
ended. 
If we need to increase or decrease the dose of mithramycin you are given, we may obtain additional 
blood samples like during Cycle 1 above. 
Additional Research Blood Samples

On Day 1 and Day 4 of Cycle 1 and on Day 1 of every cycle, blood (~3 tablespoons) will 
be collected in order to conduct research studies. 

On Day 1 of Cycles 1 and 2 blood (~less than a teaspoon) will be collected and stored in 
case it is later needed to help us determine your clinical status at these times.
Scans

CT, PET/CT and brain MRI scans to evaluate your tumor will be done after the end of each 
treatment course (every 4 cycles, ~8 weeks). 

Ultrasound study of your liver on Days 1 and 4 of Cycle 1 then on Day 1 of subsequent 
cycles. This study will also be done each time you have scans to evaluate your tumor (every 
4 cycles).
Biopsy of Tumor Tissue
You will be required to have 2 biopsies of tumor tissue in order to participate in the study.  These 
will be performed prior to starting treatment and on Day 4 of Cycle 1 to evaluate the effect of 
mithramycin on your tumor tissue. If you have sufficient tissue available from a biopsy performed 
earlier at NIH or elsewhere, you may not need to have the biopsy prior to starting treatment. A CT 
scan may be required to safely perform each tumor biopsy. 
We may request additional optional biopsies: after you have completed 1 course (4 cycles) of 
therapy, as well as if you have improvement in your disease. These optional biopsies may be 
requested only if the tumor sample can be easily obtained and the study doctor determines that the 
biopsy would not be more risk to you than usual. These optional biopsies are not required for your 
participation in the study. You will be asked at the time of the procedure whether you would like 
to give us permission to obtain these additional samples.
IRB NUMBER: 16C0152
IRB APPROVAL DATE: 12/29/2020


PATIENT IDENTIFICATION
Consent to Participate in a Clinical Research Study
NIH-2977 (4-17)
File in Section 4: Protocol Consent (1)
Version Date: 12/22/2020 
Page 5 of 13
CC ICF template v. 09.27.19
MEDICAL RECORD
CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY
Trained personnel will perform these biopsies.  If any complication occurs, we will offer medical 
care.  If upon attempting the first biopsy procedure, no tissue can be obtained or it has caused you 
harm, the second biopsy procedure will not be done.  After you are enrolled in this study, if for 
any reason the biopsies cannot be done safely, you can still receive the study drugs but the biopsies 
will not be performed.
When you are finished taking the drugs
Once the mithramycin is stopped, you will need to come back to NIH or see your local physician 
weekly for evaluation (physical exam and blood work) until you recover from any side effects.  
If your disease has remained stable or improved during the course of the study, you will also be 
seen here at NIH or by your local physician every two months for further blood tests and 
imaging studies (CT, PET/CT and MRI scans) of your tumor.
BIRTH CONTROL
If you are a woman who is breast feeding or pregnant, you may not take part in the study because 
mithramycin is known to cause birth defects and it is unknown whether or how a breastfeeding 
child might be affected by this investigational drug. If you are a woman who can become pregnant, 
or are the partner of a woman who can become pregnant, you will need to practice an effective 
form of birth control before starting study treatment, during study treatment, and for 2 months after 
you finish study treatment.  If you think that you or your partner is pregnant, you should tell your 
study doctor or nurse at once.  
Effective forms of birth control include: 
•
abstinence 

intrauterine device (IUD)
•
hormonal [birth control pills, injections, or implants]
•
tubal ligation
•
vasectomy
RISKS OR DISCOMFORTS OF PARTICIPATION
You may have side effects while on the study.  These may be caused by the study drug or the study 
procedures that you are asked to undergo. Everyone taking part in the study will be watched 
carefully for any side effects.  However, doctors don’t know all the side effects that may happen.  
Side effects may be mild or very serious. Your health care team may give you medicines to help 
lessen side effects.  Many side effects go away soon after you stop taking the mithramycin.  In 
some cases, side effects can be serious, long lasting, or may never go away.  There is a risk of rare 
occurrence of death.  We will tell you if we learn any new information that may affect your health, 
welfare, or decision to stay in this study. You should talk to your study doctor about any side 
effects that you have while taking part in the study.
Side Effects Associated with Mithramycin
Likely

Decreased blood level of calcium
IRB NUMBER: 16C0152
IRB APPROVAL DATE: 12/29/2020


PATIENT IDENTIFICATION
Consent to Participate in a Clinical Research Study
NIH-2977 (4-17)
File in Section 4: Protocol Consent (1)
Version Date: 12/22/2020 
Page 6 of 13
CC ICF template v. 09.27.19
MEDICAL RECORD
CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY

Nausea or vomiting

Diarrhea

Loss of appetite

Mouth sores

Decreased platelets (the blood cell that helps blood clot)

Decreased red blood cells (the blood cells that carry oxygen)

Abnormal levels of white blood cells (the cells that prevent infection)

Temporary increase in some liver function studies which should return to normal as soon 
as the drug is stopped
Less Likely

Bleeding including nose bleed

Fever

Drowsiness

Weakness

Tiredness

Pain, redness, soreness or swelling of the area where the IV goes in the skin

Skin changes, blushing of the face  

Headache

Mental depression, restlessness, irritability

Muscle or stomach cramps, possibly due to a low blood level of calcium 

Abnormal levels of blood elements including phosphorus or potassium.

Increase blood levels of liver enzymes, which may indicate damage to the liver

Increased blood levels of kidney function tests, such as creatinine, urea or protein
Rare but Serious

Bleeding that may require a transfusion of blood or blood products.  Bleeding may result 
in bloody or black stools, or vomiting blood, or bloody nose, or small broken blood vessels 
under the skin.

A significant rash called toxic epidermal necrolysis characterized by widespread and severe 
skin irritation has been reported with mithramycin.
While receiving mithramycin, you should avoid any drugs that contain salicylates, a component 
of aspirin, such as Aspirin, Bufferin, Ascriptin, Aspergum, Anacin, and some Alka-Seltzer 
products and some cold preparations, as they may increase the risk of bleeding.
When white blood cells are low (neutropenia), fever may be a sign of significant infection. When 
fever and neutropenia is present, hospitalization for administration of intravenous antibiotics 
may be necessary.
Because mithramycin may decrease the production of red blood cells (the part of the blood that 
carries oxygen and gives energy) and platelets (the part of the blood that helps prevent bleeding), 
it is possible that you will require transfusions with red blood cells or platelets. When these 
IRB NUMBER: 16C0152
IRB APPROVAL DATE: 12/29/2020


PATIENT IDENTIFICATION
Consent to Participate in a Clinical Research Study
NIH-2977 (4-17)
File in Section 4: Protocol Consent (1)
Version Date: 12/22/2020 
Page 7 of 13
CC ICF template v. 09.27.19
MEDICAL RECORD
CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY
transfusions are required will vary from participant to participant and can be discussed with your 
doctor. Most transfusions have no side effects.  However, you may have an allergic reaction (a 
rash, hives or very rarely, difficulty breathing that can be so severe as to result in death).  A separate 
informed consent will be obtained should you need a blood transfusion.
Side Effects Associated with Research Related Study Procedures
Blood Draw
Risks of blood sampling include pain and bleeding at the site where the blood is collected, 
lightheadedness, and rarely, fainting. When large amounts of blood are collected, low red blood 
cell count (anemia) can develop. Rarely, there is also a risk of infection at the needle site.
Urine Collection
There are no physical risks or discomforts associated with urine collection.
Ultrasound and Electrocardiogram (EKG) 
These procedures are associated with minimal discomfort.
Pulmonary Function Tests 
These tests are safe and side effects are unlikely, but may include brief light headedness or slight 
soreness of the chest.
Central Line 
In order to receive this therapy you will need to have an intravenous catheter placed. This catheter 
is usually surgically inserted in the arm, chest or neck area into one of the main blood vessels 
leading to your heart. Central catheter placement is very common and is generally well tolerated. 
The catheter is necessary for infusion of chemotherapy on this study and for the drawing of blood.  
It is usually inserted under local anesthesia.  
The risks associated with the procedure include pain, bleeding, infection, puncture of the 
underlying lung and pulmonary embolism. Lung puncture can result in lung collapse, which might 
require that a chest tube be placed into the chest cavity (usually for a day or two) to help the lung 
reinflate. The long-term risks of the catheter include infection and clotting of the vein in which the 
catheter sits, which can break off and travel to the veins near your neck, face, chest, arms or lungs 
(pulmonary embolism). If these occur, it may be necessary to remove the catheter. These risks will 
be explained to you in more detail at the time of the insertion.
Biopsy
Biopsies will be done using a small core needle under imaging guidance (CT, MRI, or ultrasound 
as deemed appropriate by the interventional radiologist performing the biopsy).  Imaging helps the 
specialized radiologist know that the needle has been placed into the tumor mass.  Typical risks of 
such procedures include, but are not limited to bleeding pain, and scarring at the biopsy site. 
Rarely, there is a risk of infection at the sampling site. If your biopsy is done under CT guidance, 
there will also be risks of radiation as described below.
Scans and Contrast
CT, PET and MRI scans are common standard imaging tests used in the diagnosis of cancer. The 
most common discomfort is the length of time a patient must lay still during a scan. Occasionally, 
IRB NUMBER: 16C0152
IRB APPROVAL DATE: 12/29/2020


PATIENT IDENTIFICATION
Consent to Participate in a Clinical Research Study
NIH-2977 (4-17)
File in Section 4: Protocol Consent (1)
Version Date: 12/22/2020 
Page 8 of 13
CC ICF template v. 09.27.19
MEDICAL RECORD
CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY
a patient may become uncomfortable with the closed space of the machines, particularly the MRI. 
If this occurs, your doctor can order a medicine to help you relax during this scan. If a contrast 
agent (the special dye) is given with the scan there is a small risk of having a reaction to the 
contrast. In that small group of patients who have a reaction, the most common symptoms are 
nausea, pain in the vein where the contrast was given, a metallic or bitter taste in the mouth, and a 
warm or flushing feeling that lasts from 1-3 minutes. Rarely do these symptoms require any 
treatment. In very rare cases, people have had severe reactions that affect their breathing and heart 
rhythm. If you have had a reaction in the past, be sure to tell you doctor or nurse about it. 
An IV line may need to be inserted for administration of the contrast agent or anesthetic.  This can 
cause pain at the site where the IV is placed and carries a small risk of bruising or infection.
What are the risks of radiation from being in the study? 
During your participation in this research study, you will be exposed to radiation from 6 CT scans, 
6 PET/CT scans as well as a maximum of 5 CT-guided biopsies over the course of the first year. 
The amount of radiation exposure you will receive from these procedures is equal to approximately 
17.8 rem. A rem is a unit of absorbed radiation.  
Every day, people are exposed to low levels of radiation that come from the sun and the 
environment around them.  The average person in the United States receives a radiation exposure 
of 0.3 rem per year from these sources.  This type of radiation is called “background radiation.”  
No one knows for sure whether exposure to these low amounts of radiation is harmful to your 
body. 
The CT scans, PET/CT scans and CT-guided biopsies that you get in this study will expose you to 
roughly the same amount of radiation as 59.3 years’ worth of background radiation. Being exposed 
to too much radiation can cause harmful side effects such as an increase in the risk of cancer. The 
risk depends on how much radiation you are exposed to. Please be aware that about 40 out of 100 
people (40%) will get cancer during their lifetime, and 20 out of 100 (20%) will die from cancer. 
The risk of getting cancer from the radiation exposure in this study is 1.8 out of 100 (1.8%) and of 
getting a fatal cancer is 0.9 out of 100 (0.9%).
POTENTIAL BENEFITS OF PARTICIPATION
Are there benefits to taking part in this study?
The potential benefit of the treatment with mithramycin is that it may cause your cancer to stop 
growing or to shrink for a period of time.  It may lessen the symptoms, such as pain, that are 
caused by the cancer.  It is unlikely that this treatment will cure your cancer.  Because there is 
not much information about the effect of mithramycin on the type of cancer that you have, we do 
not know if you will benefit from taking part in this study.  Information learned from this study 
may help future patients with cancer.
ALTERNATIVE APPROACHES OR TREATMENTS
What other choices do I have if I do not take part in this study? 
Instead of being in this study, you have these options:

Getting treatment or care for your cancer without being in a study
IRB NUMBER: 16C0152
IRB APPROVAL DATE: 12/29/2020


PATIENT IDENTIFICATION
Consent to Participate in a Clinical Research Study
NIH-2977 (4-17)
File in Section 4: Protocol Consent (1)
Version Date: 12/22/2020 
Page 9 of 13
CC ICF template v. 09.27.19
MEDICAL RECORD
CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY

Taking part in another study

Getting comfort care, also called palliative care.  This type of care helps reduce pain, 
tiredness, appetite problems and other problems caused by the cancer.  It does not treat 
the cancer directly.  Instead, it tries to improve how you feel.  Comfort care tries to keep 
you as active and comfortable as possible.
Please talk to your doctor about these and other options.
STOPPING THERAPY
Your doctor may decide to stop your therapy for the following reasons:

if he/she believes that it is in your best interest

if you become pregnant during the study

if your disease comes back during treatment

if you have side effects from the treatment that your doctor thinks are too severe

if new information shows that another treatment would be better for you
In this case, you will be informed of the reason therapy is being stopped.
You can stop taking part in the study at any time. However, if you decide to stop taking part in the 
study, we would like you to talk to the study doctor and your regular doctor first.
If you decide at any time to withdraw your consent to participate in the trial, we will not collect 
any additional medical information about you. If you withdraw your consent and leave the trial, 
any samples of yours that have been obtained for the study and stored at the NCI can be destroyed 
upon request. However, any samples and data generated from the samples that have already been 
distributed to other researchers or placed in the research databases cannot be recalled and 
destroyed.
CONFLICT OF INTEREST
The National Institutes of Health (NIH) reviews NIH staff researchers at least yearly for conflicts 
of interest.  This process is detailed in a Protocol Review Guide.  You may ask your research team 
for a copy of the Protocol Review Guide or for more information.  Members of the research team 
who do not work for NIH are expected to follow these guidelines but they do not need to report 
their personal finances to the NIH.
Members of the research team working on this study may have up to $15,000 of stock in the 
companies that make products used in this study.  This is allowed under federal rules and is not a 
conflict of interest. 
USE OF SPECIMENS AND DATA FOR FUTURE RESEARCH 
To advance science, it is helpful for researchers to share information they get from studying human 
samples.  They do this by putting it into one or more scientific databases, where it is stored along 
with information from other studies. A researcher who wants to study the information must apply 
IRB NUMBER: 16C0152
IRB APPROVAL DATE: 12/29/2020


PATIENT IDENTIFICATION
Consent to Participate in a Clinical Research Study
NIH-2977 (4-17)
File in Section 4: Protocol Consent (1)
Version Date: 12/22/2020 
Page 10 of 13
CC ICF template v. 09.27.19
MEDICAL RECORD
CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY
to the database and be approved.  Researchers use specimens and data stored in scientific databases 
to advance science and learn about health and disease.
We plan to keep some of your specimens and data that we collect and use them for future research 
and share them with other researchers. We will not contact you to ask about each of these future 
uses. These specimens and data will be stripped of identifiers such as name, address or account 
number, so that they may be used for future research on any topic and shared broadly for research 
purposes.  Your specimens and data will be used for research purposes only and will not benefit 
you.  It is also possible that the stored specimens and data may never be used.  Results of research 
done on your specimens and data will not be available to you or your doctor.  It might help people 
who have cancer and other diseases in the future.  
If you do not want your stored specimens and data used for future research, please just contact us 
in writing and let us know that you do not want us to use your specimens and/or data.  Then any 
specimens that have not already been used or shared will be destroyed and your data will not be 
used for future research. However, it may not be possible to withdraw or delete materials or data 
once they have been shared with other researchers.  
COMPENSATION, REIMBURSEMENT, AND PAYMENT
Will you receive compensation for participation in the study?
Some NIH Clinical Center studies offer compensation for participation in research. The amount 
of compensation, if any, is guided by NIH policies and guidelines.
You will not receive compensation for participation in this study. 
Will you receive reimbursement or direct payment by NIH as part of your participation?
Some NIH Clinical Center studies offer reimbursement or payment for travel, lodging or meals 
while participating in the research. The amount, if any, is guided by NIH policies and guidelines.
On this study, the NCI will cover the cost for some of your expenses.  Some of these costs may be 
paid directly by the NIH and some may be reimbursed after you have paid.  Someone will work 
with you to provide more information.
Will taking part in this research study cost you anything? 
NIH does not bill health insurance companies or participants for any research or related clinical 
care that you receive at the NIH Clinical Center. 

If some tests and procedures are performed outside the NIH Clinical Center, you may have 
to pay for these costs if they are not covered by your insurance company.

Medicines that are not part of the study treatment will not be provided or paid for by the 
NIH Clinical Center.

Once you have completed taking part in the study, medical care will no longer be provided 
by the NIH Clinical Center.
CLINICAL TRIAL REGISTRATION AND RESULTS REPORTING 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time.
IRB NUMBER: 16C0152
IRB APPROVAL DATE: 12/29/2020


PATIENT IDENTIFICATION
Consent to Participate in a Clinical Research Study
NIH-2977 (4-17)
File in Section 4: Protocol Consent (1)
Version Date: 12/22/2020 
Page 11 of 13
CC ICF template v. 09.27.19
MEDICAL RECORD
CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY
CONFIDENTIALITY PROTECTIONS PROVIDED IN THIS STUDY  
Will your medical information be kept private? 
We will do our best to make sure that the personal information in your medical record will be kept 
private.  However, we cannot guarantee total privacy.  Organizations that may look at and/or copy 
your medical records for research, quality assurance, and data analysis include:

The NIH and other government agencies, like the Food and Drug Administration (FDA), 
which are involved in keeping research safe for people.

National Institutes of Health Intramural Institutional Review Board
When results of an NIH research study are reported in medical journals or at scientific meetings, 
the people who take part are not named and identified.  In most cases, the NIH will not release any 
information about your research involvement without your written permission.  However, if you 
sign a release of information form, for example, for an insurance company, the NIH will give the 
insurance company information from your medical record.  This information might affect (either 
favorably or unfavorably) the willingness of the insurance company to sell you insurance.
If we share your specimens or data with other researchers, in most circumstances we will remove 
your identifiers before sharing your specimens or data. You should be aware that there is a slight 
possibility that someone could figure out the information is about you. 
Further, the information collected for this study is protected by NIH under a Certificate of 
Confidentiality and the Privacy Act. 
Certificate of Confidentiality
To help us protect your privacy, the NIH Intramural Program has received a Certificate of 
Confidentiality (Certificate). With this certificate, researchers may not release or use data or 
information about you except in certain circumstances.  
NIH researchers must not share information that may identify you in any federal, state, or local 
civil, criminal, administrative, legislative, or other proceedings, for example, if requested by a 
court.  
The Certificate does not protect your information when it:  
1. is disclosed to people connected with the research, for example, information may be used 
for auditing or program evaluation internally by the NIH; or 
2. is required to be disclosed by Federal, State, or local laws, for example, when information 
must be disclosed to meet the legal requirements of the federal Food and Drug 
Administration (FDA); 
3. is for other research;
4. is disclosed with your consent. 
The Certificate does not prevent you from voluntarily releasing information about yourself or your 
involvement in this research. 
The Certificate will not be used to prevent disclosure to state or local authorities of harm to self or 
others including, for example, child abuse and neglect, and by signing below you consent to those 
IRB NUMBER: 16C0152
IRB APPROVAL DATE: 12/29/2020


PATIENT IDENTIFICATION
Consent to Participate in a Clinical Research Study
NIH-2977 (4-17)
File in Section 4: Protocol Consent (1)
Version Date: 12/22/2020 
Page 12 of 13
CC ICF template v. 09.27.19
MEDICAL RECORD
CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY
disclosures. Other permissions for release may be made by signing NIH forms, such as the Notice 
and Acknowledgement of Information Practices consent.
Privacy Act
The Federal Privacy Act generally protects the confidentiality of your NIH medical records we 
collect under the authority of the Public Health Service Act.  In some cases, the Privacy Act 
protections differ from the Certificate of Confidentiality.  For example, sometimes the Privacy Act 
allows release of information from your medical record without your permission, for example, if 
it is requested by Congress. Information may also be released for certain research purposes with 
due consideration and protection, to those engaged by the agency for research purposes, to certain 
federal and state agencies, for HIV partner notification, for infectious disease or abuse or neglect 
reporting, to tumor registries, for quality assessment and medical audits, or when the NIH is 
involved in a lawsuit.  However, NIH will only release information from your medical record if it 
is permitted by both the Certificate of Confidentiality and the Privacy Act.
POLICY REGARDING RESEARCH-RELATED INJURIES  
The NIH Clinical Center will provide short-term medical care for any injury resulting from your 
participation in research here. In general, no long-term medical care or financial compensation for 
research-related injuries will be provided by the NIH, the NIH Clinical Center, or the Federal 
Government. However, you have the right to pursue legal remedy if you believe that your injury 
justifies such action.
PROBLEMS OR QUESTIONS
If you have any problems or questions about this study, or about your rights as a research 
participant, or about any research-related injury, contact the Principal Investigator, David S. 
Schrump, MD, schrumpd@mail.nih.gov, 240-760-6239. You may also call the NIH Clinical 
Center Patient Representative at 301-496-2626, or the NIH Office of IRB Operations at 301-402-
3713, if you have a research-related complaint or concern.
CONSENT DOCUMENT 
Please keep a copy of this document in case you want to read it again.
IRB NUMBER: 16C0152
IRB APPROVAL DATE: 12/29/2020


PATIENT IDENTIFICATION
Consent to Participate in a Clinical Research Study
NIH-2977 (4-17)
File in Section 4: Protocol Consent (1)
Version Date: 12/22/2020 
Page 13 of 13
CC ICF template v. 09.27.19
MEDICAL RECORD
CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY
Adult Research Participant: I have read the explanation about this study and have been given the opportunity 
to discuss it and to ask questions. I consent to participate in this study.
Signature of Research Participant
Print Name of Research Participant
Date
Legally Authorized Representative (LAR) for an Adult Unable to Consent: I have read the explanation 
about this study and have been given the opportunity to discuss it and to ask questions. I am legally authorized 
to make research decisions on behalf of the adult participant unable to consent and have the authority to provide 
consent to this study. As applicable, the information in the above consent was described to the adult participant 
unable to consent who agrees to participate in the study.
Signature of LAR
Print Name of LAR
Date
Investigator:
Signature of Investigator
Print Name of Investigator
Date
Witness to the oral short-form consent process only: This section is only required if you are doing the oral 
short-consent process and this English consent form has been approved by the IRB for use as the basis of 
translation.
Witness:
Signature of Witness*
Print Name of Witness
Date
*NIH ADMINISTRATIVE SECTION TO BE COMPLETED REGARDING THE USE OF AN 
INTERPRETER:
An interpreter, or other individual, who speaks English and the participant’s preferred language facilitated
the administration of informed consent and served as a witness. The investigator obtaining consent may not 
also serve as the witness.
An interpreter, or other individual, who speaks English and the participant’s preferred language facilitated
the administration of informed consent but did not serve as a witness. The name or ID code of the person 
providing interpretive support is:
.
IRB NUMBER: 16C0152
IRB APPROVAL DATE: 12/29/2020