Clinical trial NCT02061007: Biomarker Correlates of Hypoxia in Metastatic Melanoma
Official title: Biomarker Correlates of Hypoxia in Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Melanoma
Skin Cancer
Keywords: skin cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if magnetic resonance imaging (MRI) or positron emission tomography (PET) imaging can be used to help doctors determine how much oxygen a tumor is getting. Hypoxyprobe will be used to determine the levels of oxygen post-surgery in the current study. If the study is successful, then imaging can be used to determine a tumor's oxygen status even in patients who are not getting surgery.

Investigators want to find out how much oxygen is in the participants tumor based on how much pimo is present, and correlate this with the results of their MRI and 18F-fluoromisonidazole (FMISO) PET scan.

This study is also testing the investigational radioactive substance known as FMISO. FMISO is used during PET scans to help doctors see how much oxygen a tumor is getting. Participants might be asked to participate in an optional PET scan using FMISO.

Detailed description: A pilot phase II imaging study to determine hypoxia in melanoma.

About 16 - 24 hours before surgery, participants will be asked to come to the study center to take the investigational agent oral pimonidazole (pimo) by mouth. Pimo is a substance that is able to enter tissue when there are low levels of oxygen present (hypoxia). When the tissue is removed and visualized under a microscope, the amount of pimo present is related to the amount of oxygen in that part of the tissue. The dose of pimo given to the participant will depend on their weight (13 mg pimo/kg body weight).

After surgery, a sample of the participant's tumor tissue will be viewed by doctors under a microscope to determine the amount of pimo present.

Eligibility criteria: Inclusion Criteria:

* Must be 18 years or older with a histological diagnosis of locally advanced, recurrent or metastatic melanoma and be scheduled for clinically indicated surgical removal of one or more melanoma tumors. Additionally, patients must have a resectable tumor nodule ≥1 cm\^3 (i.e., either a spherical tumor at least 1.0 cm in diameter or a tumor measuring at least 1x1x1 cm). Prior biopsy is not required for study participation.
* Not pregnant or nursing (as confirmed by serum pregnancy test if the patient is a woman of child-bearing potential). Participants must agree with use birth control for 30 days following pimonidazole administration.
* Adequate kidney and liver function as assessed by laboratory studies
* Must be able to undergo magnetic resonance imaging (MRI) scans
* Capable of providing informed consent and demonstrate a willingness to comply with all the study procedures and visits
* Eastern Cooperative Oncology Group (ECOG) score of 0 -1

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Patients who are contraindicated for MRI or gadolinium contrast agents due to:

  * Presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, skin staples, implanted prostheses, artificial heart valves with steel parts, metal fragments, shrapnel, or other metal implants that would contraindicate MRI)
  * Sickle cell disease
  * Renal failure with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2 based upon serum creatinine
  * Weight greater than 350 lbs (the weight limit for the MRI)
* Patients with known, active (i.e. not adequately treated with curative intent) malignancies other than melanoma
* Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the participant

Primary outcomes:
measure: Percentage of Positive Biomarker Staining by Applicable Area
timeFrame: 6 weeks per participant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Jonathan Zager, M.D.
role: PRINCIPAL_INVESTIGATOR
References: