NCT00002510

Chemotherapy and Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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.

Detailed description

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	cyclophosphamide
DRUG	etoposide
DRUG	mesna
PROCEDURE	peripheral blood stem cell transplantation
RADIATION	radiation therapy

Timeline

• Start date: 1992-04-01
• Primary completion: 2001-06-01
• Completion: 2001-06-01
• First posted: 2004-08-23
• Last updated: 2010-10-01

Locations

1 site across 1 country: United States