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
Recruitment status was Active, not recruiting
|First Received Date ICMJE||February 2, 2001|
|Last Updated Date||February 6, 2009|
|Start Date ICMJE||March 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00009750 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||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|
|Official Title ICMJE||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|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Prostate Cancer|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00009750|
|Other Study ID Numbers ICMJE||CDR0000068364, UCD-992126, NCI-V00-1639|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of California, Davis|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||November 2003|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP