Chemotherapy and Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
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. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and radiation therapy and kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of etoposide plus radiation therapy followed by peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma.
|Lymphoma||Biological: filgrastim Drug: cyclophosphamide Drug: etoposide Drug: mesna Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||HIGH-DOSE CHEMORADIOTHERAPY FOLLOWED BY RESCUE WITH MOBILIZED AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH LOW-GRADE, TRANSFORMED, OR FOLLICULAR LARGE CELL NON-HODGKIN'S LYMPHOMA|
|Study Start Date:||April 1992|
|Study Completion Date:||June 2001|
|Primary Completion Date:||June 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the overall and progression-free survival of patients with selected poor-prognosis non-Hodgkin's lymphomas treated with high-dose etoposide and total-body irradiation followed by rescue with peripheral blood stem cells. II. Determine the toxicity of this regimen. III. Evaluate the short-term and long-term engraftment characteristics of patients treated on this regimen.
OUTLINE: Patients who respond on Regimen A and who have no bulk disease greater than 5 cm are treated on Regimen B. Regimen A: Single-Agent Chemotherapy/Stem Cell Mobilization with Urothelial Protection and Growth Factor Therapy. Cyclophosphamide, CTX, NSC-26271; with Mesna, NSC-113891; and Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629. Regimen B: Sequential Radiotherapy, Single-Agent Chemotherapy, and Stem Cell Rescue. Total-body irradiation, TBI (equipment not specified); Etoposide, VP-16, NSC-141540; and Peripheral Blood Stem Cells, PBSC.
PROJECTED ACCRUAL: 20 patients will be studied.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002510
|United States, Pennsylvania|
|Temple University Cancer Center|
|Philadelphia, Pennsylvania, United States, 19140|
|Study Chair:||Thomas R. Klumpp, MD||Fox Chase Cancer Center|