Clinical trial NCT01321008
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
Sponsor: M.D. Anderson Cancer Center
Start date: 2011-05-01; Completion date: 2013-05-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: 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), Doxorubicin 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.
Interventions: intervention 1: Radiation intervention 2: Cyclophosphamide intervention 3: Doxorubicin intervention 4: Vincristine intervention 5: Prednisone
Intervention descriptions: intervention 1: 50.4 to 54 Gy delivered 5 days a week for 28 to 30 treatments. intervention 2: 750 mg/m2 by vein over 1 hour on Day 1 of a 21 day cycle. intervention 3: 50 mg/m2 by vein over 15 minutes on Day 1 of a 21 day cycle. intervention 4: 1.4 mg/m2 (max dose 2 mg) by vein over 15 minutes on Day 1 of a 21 day cycle. intervention 5: 100 mg by mouth daily on Days 1-5 of a 21 day cycle.

Protocol documents: