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

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

Summary

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver tumor-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. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy, cyclosporine, and paclitaxel followed by peripheral stem cell transplantation in treating patients who have refractory non-Hodgkin's lymphoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Treatments: Albumin-Bound Paclitaxel; Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Cyclosporine; Cyclosporins; Immunoglobulins; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-Hodgkin's lymphoma (NHL) that has failed standard therapy

• Any grade allowed

• Intermediate or high grade NHL must have failed standard therapy with curative intent

• Measurable disease

• HAMA titer negative

• NHL tissue Lym-1 reactive in vitro

• Bilateral bone marrow biopsy less than 25% NHL

• No evidence of myelodysplastic syndrome in bone marrow NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 130,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• AST no greater than 84 U/L

Renal:

• Creatinine less than 1.5 mg/dL OR

• Creatinine clearance at least 50 mL/min

Cardiovascular:

• LVEF at least 50%

Pulmonary:

• FEV1 at least 60% of predicted

• FVC at least 60% of predicted

• Corrected DLCO at least 50%

Other:

• No other malignancy within the past 5 years except for non- melanoma skin cancer

• HIV negative

• No AIDS

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy involving more than 25% of bone marrow

• At least 4 weeks since prior external beam radiotherapy

Surgery:

• Not specified