Ignite Creation Date:
2024-05-04 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003400
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Prostate Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
High Dose Chemotherapy With Stem Cell Rescue Followed By Consolidation Treatment in Patients With Metastatic Hormone-Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation followed by combination chemotherapy in treating patients with metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation followed by combination chemotherapy in treating patients with metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Evaluate the complete and partial remission rates and event free and overall survival of patients with metastatic hormone refractory prostate cancer treated with high dose chemotherapy plus peripheral stem cell transplantation followed by consolidation chemotherapy II Evaluate the toxic effects associated with this treatment in these patients III Evaluate the quality of life and need for analgesics in these patients
OUTLINE Patients are stratified by stage of disease and extent of metastatic disease Patients receive daily filgrastim G-CSF subcutaneously for 4 days until peripheral blood stem cells are collected Patients then receive carmustine IV over 2 hours on day -2 and melphalan IV over 20 minutes on day -1 Stem cell infusion will be on day 0 At 3 6 9 and 12 months after transplant patients receive vinorelbine IV over 10 minutes and cisplatin IV over 24 hours Quality of life and pain are assessed before the transplantation just before discharge after transplantation prior to each consolidation course and then at 3 6 and 12 months after the final course of chemotherapy Patients are followed at least every 3 months for the first 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 18-45 patients will be accrued for this study within 2 years
OUTLINE Patients are stratified by stage of disease and extent of metastatic disease Patients receive daily filgrastim G-CSF subcutaneously for 4 days until peripheral blood stem cells are collected Patients then receive carmustine IV over 2 hours on day -2 and melphalan IV over 20 minutes on day -1 Stem cell infusion will be on day 0 At 3 6 9 and 12 months after transplant patients receive vinorelbine IV over 10 minutes and cisplatin IV over 24 hours Quality of life and pain are assessed before the transplantation just before discharge after transplantation prior to each consolidation course and then at 3 6 and 12 months after the final course of chemotherapy Patients are followed at least every 3 months for the first 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 18-45 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V98-1436 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066404 | REGISTRY | None | None |