Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies 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 transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well monoclonal antibody therapy, chemotherapy, and peripheral stem cell transplant work in treating patients with relapsed or refractory non-Hodgkin's lymphoma.

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

Details

• Lead Sponsor: University of Nebraska
• Treatments: Antibodies; Antibodies, Monoclonal; Cadexomer iodine; Carmustine; Cytarabine; Etoposide; Immunoglobulins; Iodine; Iodine-131 anti-B1 antibody; Melphalan; Tositumomab I-131

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of non-Hodgkin's lymphoma (NHL) of one of the following types:

• Diffuse large B-cell

• Composite (at least 50% of tumor showing diffuse histology)

• Diffuse mixed cell

• Immunoblastic

• Relapsed or refractory disease sensitive to initial or subsequent conventional therapy (at least a partial response)

• Eligible for high-dose carmustine, etoposide, cytarabine, and melphalan protocol and autologous bone marrow transplantation or peripheral blood stem cell transplantation

• Evidence of CD20 antigen expression in tumor tissue

• Bidimensionally measurable disease

• No progressive disease in a field that has been previously irradiated with more than 3,500 cGy within the past year

• Adequate peripheral blood stem cells

• At least 15,000,000 CD34+ cells/kg OR

• At least 25,000 granulocyte macrophage colony-forming units/kg

• No known brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

Age:

• 19 to 70

Performance status:

• Karnofsky 70-100%

Life expectancy:

• At least 4 months posttransplantation

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin less than 2.0 mg/dL

Renal:

• Creatinine less than 2.0 mg/dL

• No active obstructive hydronephrosis

Cardiovascular:

• Cardiac ejection fraction at least 40% for any of the following criteria:

• Age 60 and over

• Significant cardiac history (myocardial infarction or congestive heart failure)

• Received greater than 350 mg/m^2 of prior doxorubicin

• No New York Heart Association class III or IV heart disease

Pulmonary:

• DLCO at least 50% of predicted

Other:

• No evidence of severe organ dysfunction

• No other major medical illnesses

• No active infection requiring IV antibiotics

• No other malignancy within the past 5 years except adequately treated skin cancer or carcinoma in situ of the cervix

• HIV negative

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 6 months after study participation

• Human antimouse antibody negative

• No vulnerability

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

• No prior peripheral blood stem cell transplantation following high-dose chemotherapy or chemoradiotherapy

• At least 4 weeks since prior biologic therapy and recovered

• No other concurrent biologic therapy for NHL

Chemotherapy:

• See Disease Characteristics

• See Biologic therapy

• At least 4 weeks since prior cytotoxic chemotherapy and recovered

• No other concurrent chemotherapy or antineoplastic therapy for NHL

Endocrine therapy:

• No concurrent steroids except maintenance-dose steroids for noncancerous disease

Radiotherapy:

• See Disease Characteristics

• See Biologic therapy

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent external beam radiotherapy for NHL

Surgery:

• Not specified

Other:

• At least 4 weeks since prior immunosuppressants and recovered

• No other concurrent participation on protocol involving non-FDA-approved drugs or biologics