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

Study Description

Brief Summary: 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. 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

Detailed Description: PRIMARY OBJECTIVES: I. To compare the survival and disease-free survival of patients with non-Hodgkin's lymphoma treated with post-transplant therapy with interleukin-2 (IL-2) or no further treatment. Transplant therapy is total body irradiation (TBI), high-dose etoposide, cyclophosphamide and peripheral blood stem cell transplant (PBSCT). II. To assess the frequency and severity of toxicity associated with post-transplant IL-2 therapy. 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.

Keywords

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

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Contact Details

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