Stage I/II Nasal NK Cell Lymphoma
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Lymphoma |
| Intervention | Radiation: Radiation Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone |
| Phase | Phase 1/Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Responsible Party | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier | NCT01321008 |
| First Received | March 21, 2011 |
| Last Updated | May 10, 2013 |
| Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 21, 2011 |
|---|---|
| Last Updated Date | May 10, 2013 |
| Start Date | May 2011 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Progression-free survival (PFS) [Time Frame: Day 1 to disease progression or death (up to 5+ years)] [Designated as safety issue: Yes]Progression-free survival (PFS) defined as time from treatment initiation day to first documented progressive disease or death due to disease. Reviewed with each 21-day treatment cycle, followed every 3-4 months for first 2 years, annually thereafter. |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
| 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 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 ECHO and MUGA scan. - You will have an x-ray of the chest. - You will have an 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 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. - 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. This is an investigational study. Radiation and CHOP are FDA approved and commercially available for patients with stage 1 and/or 2 NK cell lymphoma. The collection of long term information about this treatment is investigational. Up to 40 patients will take part in this study. All will be enrolled at MD Anderson. |
| Study Type | Interventional |
| Study Phase | Phase 1/Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Lymphoma |
| Intervention | Radiation: Radiation 50.4 to 54 Gy delivered 5 days a week for 28 to 30 treatments. Other Names:
750 mg/m2 by vein over 1 hour on Day 1 of a 21 day cycle. Other Names:
50 mg/m2 by vein over 15 minutes on Day 1 of a 21 day cycle. Other Names:
1.4 mg/m2 (max dose 2 mg) by vein over 15 minutes on Day 1 of a 21 day cycle. Other Names: OncovinDrug: Prednisone 100 mg by mouth daily on Days 1-5 of a 21 day cycle. |
| Study Arm (s) | Experimental: Radiation + Chemotherapy Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Adriamycin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
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| Estimated Enrollment | 1 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | May 2013 |
| Eligibility Criteria | Inclusion Criteria: 1. Patients with newly diagnosed stage I and II nasal NK cell lymphoma. 2. Adequate blood cell counts (i.e. 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 the upper limit of normal (ULN), * Alanine transaminase (ALT) 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 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 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01321008 |
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| Other Study ID Numbers | 2010-0035 |
| Has Data Monitoring Committee | No |
| Information Provided By | M.D. Anderson Cancer Center |
| Study Sponsor | M.D. Anderson Cancer Center |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Bouthaina Dabaja, MD UT MD Anderson Cancer Center |
| Verification Date | May 2013 |
Locations[ + expand ][ + ]
| UT MD Anderson Cancer Center | Houston, Texas, United States, 77030 |
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