Clinical trial NCT00126191
Conditions: Burkitt Lymphoma Non-Hodgkins Lymphoma Atypical Burkitt Lymphoma
Keywords: Burkitt Lymphoma atypical Burkitt lymphoma Non-Hodgkin's Lymphoma rituximab
Sponsor: Dana-Farber Cancer Institute
Start date: 2005-07-01; Completion date: 2011-06-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn more about how well a chemotherapy regime including rituximab works in treating patients with Burkitt or atypical Burkitt lymphoma.

Detailed description:
* Patients will be placed into one of two groups, "low risk" and "high risk". "Low risk" disease is defined as one area of disease measuring less than 10cm and a normal blood test called LDH (lactate hydrogenase). Patients not fitting the "low risk" criteria are considered "high risk".
* If the patient has "low risk" disease their treatment cycle consist of three cycles of A.
* If the patient has "high risk" disease they will receive Cycle A followed by cycle B which will then repeat.
* Cycle A consists of the drugs: rituximab, cyclophosphamide, oncovin, doxorubicin and methotrexate (R-CODOX-M). The treatment cycle is approximately 14 days. A spinal tap is performed on day 1 and day 3 of the cycle and the patient will be hospitalized until between day 11 and day 13. After the patient's blood counts return to normal(usually around day 21),the next round of treatment will occur.
* Cycle B consists of the drugs: rituximab, ifosfamide, VP-16 and ara-c (IVAC). The treatment cycle is approximately 5 days. A spinal tap is performed on day 4 and once blood counts return to normal the patient will start cycle A again.
* After the patient has finished the treatments, they will be re-evaluated with CT scans and PET scans to determine whether or not they are in remission. Every three months for two years, blood tests and CT and PET scans will be performed. Follow up after that will be every 6 months for two years.

Arms: arm 1: Low-risk patients receive 3 cycles of regimen A.

Regimen A:

Rituximab (375 mg/m\^2) on Days 1 and 3. Cyclophosphamide (800 mg/m\^2) on days 1 and 2. Vincristine (1.4 mg/m\^2) on days 1 and 10. Doxorubicin (50 mg/m\^2) on Day 1. Methotrexate (3000 mg/m\^2) on Day 10. Intrathecal Cytarabine (50mg) will be given on Day 1 and intrathecal methotrexate (12mg) will be given on Days 1 and 10.

Leucovorin on days 11 and 12.

Rituximab is given on Days 1 and 3 in cycle 1, and on Day 1 of all other cycles. arm 2: High-risk patients receive 4 alternating cycles of regimens A and B (A-B-A-B).

Regimen A (as described earlier).

Regimen B:

Rituximab (375mg/m\^2) on Day 1. Ifosfamide (1500mg/m\^2) on Days 1-5. Mesna (275 mg/m\^2) on Days 1-5. Etoposide (60mg/mg\^2) on Days 1-5. Cytarabine (2 gm/m\^2) twice a day on Days 1 and 2. Intrathecal methotrexate (12mg) on Day 5, and intrathecal methotrexate (50mg) on Day 3 (also on Day 1 for patients with central nervous system involvement).
Interventions: intervention 1: Rituximab intervention 2: Cyclophosphamide intervention 3: Doxorubicin intervention 4: Vincristine intervention 5: Methotrexate intervention 6: Leucovorin intervention 7: Ifosfamide intervention 8: Etoposide intervention 9: Cytarabine intervention 10: Mesna
Intervention descriptions: intervention 1: Low Risk: Intravenously on Day 3 of the first cycle (One cycle is 14 days) then day 1 for next 2 cycles (Regimen A) High Risk: Regimen A followed by a 5-day cycle where rituximan is given on day 1 intervention 2: Low Risk/High Risk: Intravenously on day 1 and day 2 of a 14-day cycle for 3 cycles (regimen A) intervention 3: Low Risk/High Risk: Given on day 1 of a 14-day cycle for 3 cycles (regimen A) intervention 4: Low Risk/High Risk: Given intravenously on day 1 and day 10 of a 14-day cycle for 3 cycles (regimen A) intervention 5: Low Risk: Given on day 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: Regimen A followed by methotrexate on day 3 and day 5 of a 5-day cycle intervention 6: Low Risk/High Risk: Given on days 11, 12 and 13 of a 14-day cycle for 3 cycles (regimen A) intervention 7: High Risk: After Regimen A, Ifosomide given on days 1-5 of a 5 day cycle intervention 8: High Risk: After Regimen A, etoposide given days 1-5 of a 5-day cycle intervention 9: Low Risk: Given on days 1, 3, 5 and 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: After regimen A, cytarabine given on days 1 and 2 of a 5-day cycle intervention 10: High Risk: After regimen A, mesna is given on days 1-5 of a 5-day cycle

Protocol documents: