Monoclonal Antibody Therapy, Paclitaxel, and Cyclosporine in Treating Patients With Recurrent or 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 tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with cyclosporine and paclitaxel may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy combined with paclitaxel and cyclosporine in treating patients who have recurrent or 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:

• Diagnosis of non-Hodgkin's lymphoma (NHL) that has failed standard first-line chemotherapy

• Measurable disease

• NHL tissue Lym-1 reactive in vitro

• Normocellular bone marrow as evidenced by less than 25% of the bone marrow being NHL by bilateral bone marrow biopsy

• No bone marrow evidence of myelodysplastic syndrome

• HAMA titer negative

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• 3 to 6 months

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

• DLCO at least 50%

Other:

• No other prior malignancy within the past 5 years except for nonmelanoma skin cancer

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior external beam radiotherapy

Surgery:

• Not specified