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Sponsored by: |
University of California, Davis |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00009750 |
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: cyclosporine Drug: filgrastim Drug: indium In 111 monoclonal antibody m170 Drug: monoclonal antibody m170 Drug: paclitaxel Drug: yttrium Y 90 monoclonal antibody m170 Procedure: peripheral blood stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Combined Modality Radioimmunotherapy For Hormone Refractory Metastatic Prostate Cancer With Two Cycles Of Escalating Dose 90Y-DOTA-Peptide-m170 And Fixed, Low Dose Paclitaxel With Blood Stem Cell Support And Cyclosporin For HAMA Suppression |
Study Start Date: | March 2001 |
OBJECTIVES:
OUTLINE: This is an open-label, dose-escalation study of yttrium Y 90 monoclonal antibody m170 (Y90 MOAB m170). Patients are assigned to one of four cohorts.
After the first occurrence of hematologic dose-limiting toxicity in a patient, all subsequent patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 4 days prior to undergoing apheresis and continuing until 6 million CD34+ cells/kg are collected. After 2 patients in a cohort group experience hematologic dose-limiting toxicity, subsequent patients undergo autologous peripheral blood stem cell (PBSC) transplantation.
Cohorts of 3 to 6 patients receive escalating doses of Y90 MOAB m170 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 3 months, every 3 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study within 36 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 |
Study Chair: | Carol M. Richman, MD | University of California, Davis |
Study ID Numbers: | CDR0000068364, UCD-992126, NCI-V00-1639 |
Study First Received: | February 2, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00009750 |
Health Authority: | United States: Federal Government |
stage IV prostate cancer recurrent prostate cancer |
Cyclosporine Genital Neoplasms, Male Prostatic Diseases Clotrimazole Miconazole Tioconazole Urogenital Neoplasms Genital Diseases, Male |
Cyclosporins Recurrence Antibodies, Monoclonal Antibodies Paclitaxel Prostatic Neoplasms Immunoglobulins |
Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Antifungal Agents Therapeutic Uses Tubulin Modulators Antirheumatic Agents Antineoplastic Agents, Phytogenic Dermatologic Agents |