Spots Global Cancer Trial Database for Combination Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy, radiation therapy, and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy, radiation therapy, and peripheral stem cell transplantation in treating patients who have stage III or stage IV mantle cell lymphoma.

Detailed Description: OBJECTIVES: I. Evaluate the response to a 8 week induction chemotherapy program consisting of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with mantle cell lymphoma. II. Evaluate the efficacy of ifosfamide, carboplatin, and etoposide (ICE) chemotherapy and filgrastim (G-CSF) for peripheral blood stem cell (PBSC) mobilization in this patient population. III. Evaluate the safety and efficacy of ICE followed by total body irradiation and high dose cyclophosphamide and etoposide in this patient population. IV. Assess the contamination of PBSCs by lymphoma cells following mobilization by chemotherapy and G-CSF in this patient population. OUTLINE: Patients receive induction chemotherapy with cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, oral prednisone daily on days 2-6, and filgrastim (G-CSF) subcutaneously daily on days 6-10. Treatment is repeated every 14 days for up to 4 courses. Patients receive consolidation chemotherapy with ifosfamide IV over 24 hours and carboplatin IV on day 2, etoposide IV daily on days 1-3, and G-CSF subcutaneously on days 5-12 for course 1, and on day 5 for course 2 and continuing through peripheral blood stem cell (PBSC) collection. Treatment is repeated every 14 days for 2 courses. Following PBSC collection, patients receive total body irradiation twice a day for 4 days plus etoposide IV over 72 hours on days -6, -5, and -4 and cyclophosphamide IV daily on days -3 and -2. PBSCs are infused on day 0. Patients receive G-CSF IV or subcutaneously twice a day beginning on day 1. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter. PROJECTED ACCRUAL: Approximately 14-24 patients will be accrued for this study within two years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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