Combination Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Lymphoma Clinical Trial

Official title: Phase II Study of High-Dose Cytarabine, Cisplatin, and Dexamethasone Followed By Cyclophosphamide, Etoposide, Total Body Irradiation, and Autologous Bone Marrow Rescue in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Status Active, not recruiting

Clinical Trial 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. Bone marrow transplantation may allow doctors to give higher doses of radiation therapy and chemotherapy and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of high-dose etoposide and cyclophosphamide plus total-body irradiation followed by bone marrow transplantation in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Clinical Trial Description

OBJECTIVES: I. Determine the toxicity and activity of cyclophosphamide, etoposide, total body irradiation, and autologous bone marrow transplantation in patients with relapsed or refractory non-Hodgkin's lymphoma. II. Determine the feasibility of pretransplantation cytoreduction with a regimen of high-dose cytarabine, cisplatin, and dexamethasone in this patient population. III. Determine the feasibility of posttransplantation radiotherapy given to sites of residual disease (involved-field "boost" irradiation) in this patient population.

OUTLINE: Patients are stratified by disease status (refractory vs relapsed). Autologous bone marrow is harvested before cytoreduction or involved field radiotherapy (IFRT). Patients with marrow involvement who achieve marrow complete response after cytoreduction undergo harvest of bone marrow before IFRT. Patients receive cytoreduction comprising high-dose cytarabine IV over 1 hour every 12 hours, cisplatin IV over 10 hours, and dexamethasone three times daily on days 1 and 2. At 3 weeks, a second course is administered if tumor reduction is at least 25% and in the absence of unacceptable toxicity. Patients with involved sites 2 cm or greater in diameter at evaluation and previously unirradiated active disease sites, at least 90% of which can be treated with IFRT, undergo IFRT 5 days a week for 2 weeks beginning after cytoreduction and 3-5 weeks after harvest of bone marrow. Within 10 days after completion of IFRT, patients receive etoposide IV over 26 hours beginning on day -7, cyclophosphamide IV over 2 hours on days -6 to -4, and total body irradiation twice daily on days -3 and -2 and once on day -1. Bone marrow is reinfused on day 0. Eligible patients with residual disease at 3 months after transplantation undergo involved field "boost" irradiation to sites of residual disease.

PROJECTED ACCRUAL: Approximately 50 patients (25 per stratum) will be accrued for this study. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

• NCT number: NCT00002481
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 1990