Clinical trial NCT01321008: Stage I/II Nasal NK Cell Lymphoma
Official title: Radiation Therapy Followed by Chemotherapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Lymphoma
Keywords: NK cell lymphoma-nasal type
Stage I/II
Radiation therapy
XRT
chemotherapy
CHOP
Cyclophosphamide
Cytoxan
Neosar
Adriamycin
Doxorubicin
Rubex
Vincristine
Oncovin
Prednisone
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical research study is to learn if radiation therapy and chemotherapy can help control stage 1 and/or 2 NK cell lymphoma. The safety of radiation and chemotherapy will also be studied.

Detailed description: The Study Treatments:

Radiation therapy is designed to kill cancer cells or to stop cancer cells from growing.

CHOP chemotherapy is made up of the drugs cyclophosphamide, hydroxydaunorubicin (doxorubicin), oncovin (vincristine), and prednisone. It is designed to help control the tumor locally as well as the tumor cells that might have escaped and moved through the body.

Radiation Therapy:

You will receive radiation therapy 5 days a week for 28 to 30 treatments. You will receive a separate consent form that will describe this procedure and its risks in more detail.

Study Visits During Radiation Therapy:

Every week for 6 weeks during radiation therapy:

* You will be asked how you are feeling and about any side effects you may be having.
* Your performance status will be recorded.
* You will have a physical exam.

Chemotherapy Administration:

The amount of time after you finish radiation therapy before you can begin receiving chemotherapy will depend on your recovery time and any side effects you may have. This should be about 3-4 weeks.

On Day 1 you will receive cyclophosphamide by vein over 1 hour, doxorubicin by vein over 15 minutes, and vincristine by vein over 15 minutes. You will take prednisone by mouth on Days 1-5 of each cycle. Each cycle will be 21-days long (or longer if it takes longer for your blood counts to recover). You will receive up to 4 cycles of chemotherapy.

Study Visits During Chemotherapy:

Before Day 1 of Cycle 1:

* You will have a CT scan of head, neck, chest, abdomen and pelvis.
* You will have an Magnetic resonance imaging (MRI) scan of the head and neck.
* You will be asked about any drugs you may be taking and symptoms you may be having.
* Your performance status will be recorded.
* You will have a physical exam, including measurement of your height and weight.
* You will have an echocardiogram (ECHO) and MUltiple Gated Acquisition scan (MUGA) scan.
* You will have an x-ray of the chest.
* You will have an Electrocardiography (ECG).
* Blood (about 2 teaspoons) will be drawn for routine tests.
* If you are able to become pregnant, you will have a blood (about 2 teaspoons) pregnancy test.

On Day 15 of Cycle 1:

* You will be asked about any drugs you may be taking and symptoms you may be having.
* Your performance status will be recorded.
* Blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of Cycles 2-4:

* You will be asked about any drugs you may be taking and symptoms you may be having.
* Your performance status will be recorded.
* You will have an ECG.
* Blood (about 2 teaspoons) will be drawn for routine tests.

On Day 15 of Cycles 2-4:

-Blood (about 2 teaspoons) will be drawn for routine tests.

Length of Study:

You may receive radiation and up to 4 cycles of CHOP. You will no longer be able to receive CHOP if the disease gets worse or intolerable side effects occur.

Your participation on the study will be over after the end-of-study and follow-up visits.

Follow-Up and End-of-Study Visits:

If you leave the study early:

* You will have a computed tomography (CT) scan of head, neck, chest, abdomen and pelvis.
* You will have an MRI scan of the head and neck.
* You will have a positron emission tomography (PET)/CT scan.
* Any skin lesions that you may have that are related to the tumor will be measured and photographed.
* You will be asked about any drugs you may be taking and symptoms you may be having.
* Your performance status will be recorded.
* You will have a physical exam.
* Blood (about 2 teaspoons) will be drawn for routine tests.

Routine Follow-up:

* You will also have routine follow-up visits every 3 months for the 1st year, every 4 month during the 2nd year, and every 6 months during the 3rd-5th years. After that, you will have follow up visits 1 time every year. At these visits, the following tests and procedures will be recorded:
* You will have a CT scan of head, neck, chest, abdomen and pelvis.
* You will have an MRI scan of the head and neck.
* You will have a PET/CT scan.
* You will be asked about any symptoms you may be having.
* Blood (about 2 teaspoons) will be drawn for routine tests.

Up to 40 patients will take part in this study. All will be enrolled at University of Texas (UT) MD Anderson Cancer Center.

Eligibility criteria: Inclusion Criteria:

1. Patients with newly diagnosed stage I and II nasal Natural Killer (NK) cell lymphoma.
2. Adequate blood cell counts (i.e. Absolute neutrophil count (ANC)\> 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and Epoetin. Epoetin will not be administered concurrently with radiation.
3. Patients must have adequate liver function as indicated by: \*Bilirubin \</= 1.5 times the upper limit of normal (ULN), \* Alanine transaminase (ALT) \</= 2 times the (ULN) or aspartate transaminase (AST) ≤ 2 times the ULN, \*These values must be obtained within two weeks before protocol entry.
4. Patients are required to have adequate renal function as indicated by a serum creatinine \</= 2.5 mg/dL.This value must be obtained within two weeks before protocol entry.
5. Left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure \>/= 50%.
6. Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.
7. Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses \> two years or surgically sterilized).
8. Female patients of childbearing potential must have a negative serum pregnancy test (BhCG) within 2 weeks of protocol entry.
9. Patients must have the ability to give informed consent.

Exclusion Criteria:

1. Patients with active Hepatitis B and/or Hepatitis C infection.
2. Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
3. Patients known to be HIV positive.
4. Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes: a) Congestive heart failure class III/IV (CHF) per new york heart association (NYHA) criteria. b) Cardiomyopathy, c) Uncontrolled cardiac arrhythmia, d) Unstable angina pectoris, e) Recent Myocardial infarction (MI) (within 6 months).
5. Patients with prior exposure to anthracyclines:
6. Patients who are pregnant or breast-feeding.
7. Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.
8. Prior radiation to the site of current primary disease, if re-treatment would lead to violation of known radiation dose tolerance limits for that site.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Day 1 to disease progression or death (up to 5+ years)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Bouthaina Dabaja, MD
role: PRINCIPAL_INVESTIGATOR
References: