Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009750
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2001-02-02
Brief Title:
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
Sponsor:
University of California Davis
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2003-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of yttrium Y90 monoclonal antibody m170 administered with paclitaxel and cyclosporine followed by autologous peripheral blood stem cell transplantation in patients with hormone-refractory metastatic prostate cancer
Determine the preliminary efficacy of this regimen in these patients
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 cellskg are collected After 2 patients in a cohort group experience hematologic dose-limiting toxicity subsequent patients undergo autologous peripheral blood stem cell PBSC transplantation
Cohort I Patients receive unlabeled monoclonal antibody MOAB m170 IV over 5 minutes followed by a tracer dose of indium In 111 monoclonal antibody m170 In111 MOAB m170 IV over 5-10 minutes on day 0 and unlabeled MOAB m170 IV followed by Y90 MOAB m170 IV on day 7 Patients also receive oral cyclosporine every 12 hours on days -3 to 25 Patients may undergo autologous PBSC transplantation on day 21 and receive G-CSF SC daily beginning on day 21 and continuing until blood counts recover
Cohort II Patients receive treatment as in cohort I Patients also receive paclitaxel IV over 3 hours on day 9
Cohort III and IV Patients receive treatment as in cohort I without In111 MOAB m170 Patients also receive paclitaxel as in cohort II
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
Determine the maximum tolerated dose of yttrium Y90 monoclonal antibody m170 administered with paclitaxel and cyclosporine followed by autologous peripheral blood stem cell transplantation in patients with hormone-refractory metastatic prostate cancer
Determine the preliminary efficacy of this regimen in these patients
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 cellskg are collected After 2 patients in a cohort group experience hematologic dose-limiting toxicity subsequent patients undergo autologous peripheral blood stem cell PBSC transplantation
Cohort I Patients receive unlabeled monoclonal antibody MOAB m170 IV over 5 minutes followed by a tracer dose of indium In 111 monoclonal antibody m170 In111 MOAB m170 IV over 5-10 minutes on day 0 and unlabeled MOAB m170 IV followed by Y90 MOAB m170 IV on day 7 Patients also receive oral cyclosporine every 12 hours on days -3 to 25 Patients may undergo autologous PBSC transplantation on day 21 and receive G-CSF SC daily beginning on day 21 and continuing until blood counts recover
Cohort II Patients receive treatment as in cohort I Patients also receive paclitaxel IV over 3 hours on day 9
Cohort III and IV Patients receive treatment as in cohort I without In111 MOAB m170 Patients also receive paclitaxel as in cohort II
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1639 | None | None | None |
| UCD-992126 | None | None | None |