Cyclophosphamide W/or W/Out Rituximab and Peripheral Stem Cell Transplantation in Patients With Recurrent Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known if combining rituximab with cyclophosphamide is more effective than cyclophosphamide alone in stimulating peripheral stem cells for transplantation.

PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide with or without rituximab followed by chemotherapy and peripheral stem cell transplantation works in treating patients with recurrent non-Hodgkin's lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carmustine; Cisplatin; Cyclophosphamide; Etoposide; Etoposide phosphate; Lenograstim; Rituximab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL)

• Indolent or aggressive histology

• No small lymphocytic lymphoma, Burkitt's lymphoma, or small lymphocytic non-Burkitt's lymphoma

• CD20-positive and/or CD19-positive by immunohistochemistry or flow cytometry

• Second or greater remission allowed

• Partial remission, relapse, or refractory disease must have measurable tumor

• Eligible for high-dose therapy followed by autologous peripheral blood stem cell transplantation

• No CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Age:

• 12 to 65

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,200/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin less than 2.0 mg/dL

Renal:

• Creatinine clearance at least 60 mL/min

• No renal dysfunction

Cardiovascular:

• LVEF at least 40%

• No cardiac dysfunction

• No myocardial infarction within the past 3 months

Pulmonary:

• FEV_1 greater than 60%

• DLCO at least 60% of predicted

• No pulmonary dysfunction

• No asthma

Other:

• HIV negative

• No significant organ dysfunction

• No severe comorbid condition

• No uncontrolled diabetes

• No severe or active infection

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Chemotherapy

• No prior immunotherapy

Chemotherapy:

• No prior high-dose chemotherapy with or without peripheral blood stem cell transplantation

• No more than 3 prior chemotherapy regimens for NHL

• At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

• Not specified

Radiotherapy:

• Prior radiotherapy allowed

Surgery:

• Not specified