Monoclonal Antibody Therapy Plus Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

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

Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor 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 tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy and chemotherapy with peripheral stem cell transplantation may be an effective treatment for metastatic prostate cancer.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy plus chemotherapy followed by peripheral stem cell transplantation in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

• 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; Hormones; Immunoglobulins; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed hormone-refractory metastatic prostate cancer

• Hormonal ablation (surgical or chemical) at least 3 months prior to study

• HAMA titer negative

• Less than 25% bone marrow involvement by metastatic prostate cancer

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 100,00/mm^3

• Hemoglobin at least 10.0 g/dL (without transfusion)

• No chronic transfusion requirement

Hepatic:

• Bilirubin no greater than 1.3 mg/dL

• AST no greater than 1.5 times normal

Renal:

• Creatinine less than 1.5 mg/dL

Cardiovascular:

• LVEF at least 50% by MUGA

• No disseminated intravascular coagulation

Pulmonary:

• FEV1 at least 65% of predicted

• FVC at least 65% of predicted

• Corrected DLCO at least 60%

Other:

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior murine protein (e.g., ProstaScint)

Chemotherapy:

• At least 4 weeks since prior standard dose chemotherapy

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• At least 4 weeks since prior external beam radiotherapy

• No prior radiotherapy to no more than 25% of total skeleton

Surgery:

• See Disease Characteristics

Other:

• No concurrent oral anticoagulants (low dose coumadin for central line thrombosis prophylaxis allowed)

• No concurrent chronic transfusions