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Interleukin-2 or Observation Following Radiation Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

2014-08-27 03:59:02 | BioPortfolio

Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill non-Hodgkin's lymphoma cells. Giving interleukin-2 after radiation therapy, chemotherapy, and peripheral stem cell transplantation may kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of interleukin-2 with that of observation following radiation therapy, combination chemotherapy, and peripheral stem cell transplantation in treating patients who have refractory or relapsed non-Hodgkin's lymphoma.

Description

OBJECTIVES:

- Compare the overall and disease-free survival of patients with non-Hodgkin's lymphoma treated with interleukin-2 (IL-2) vs observation only after total-body irradiation, high-dose etoposide, cyclophosphamide, and autologous peripheral blood stem cell transplantation.

- Determine the frequency and severity of toxic effects associated with posttransplantation IL-2 in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease grade (low vs intermediate vs high), chemosensitive disease (yes vs no), partial or complete response after initial induction chemotherapy (yes vs no), and performance status (0-1 vs 2).

- Part I: Autologous peripheral blood stem cells (PBSC) are harvested before study entry. Patients undergo total body irradiation twice a day on days -8 to -5, high-dose etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 1 hour on day -2. PBSC are reinfused on day 0 and then filgrastim (G-CSF) may be administered subcutaneously or IV on days 0-21.

- Part II: Within 28-80 days after PBSC transplantation and after recovery from any toxic effects, patients with no active recurrent or progressive disease are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive interleukin-2 IV continuously on days 1-4 and 9-18.

- Arm II: Patients undergo observation only. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 275 patients will be accrued for this study within 3.5-5.9 years.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment

Conditions

Lymphoma

Intervention

aldesleukin, filgrastim, cyclophosphamide, etoposide, bone marrow ablation with stem cell support, peripheral blood stem cell transplantation, radiation therapy

Location

Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson
Arizona
United States
85724

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:02-0400

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