Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002600
Status:
COMPLETED
Last Update Posted:
2019-02-06
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Bone Marrow Transplantation and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A PHASE I TRIAL OF HIGH DOSE CHEMOTHERAPY WITH AUTOLOGOUS BONE MARROW AND PERIPHERAL BLOOD PROGENITOR CELL RESCUE IN PATIENTS WITH PLATINUM-SENSITIVE CHEMOTHERAPY-RESPONSIVE EPITHELIAL OVARIAN CARCINOMA
Status:
COMPLETED
Status Verified Date:
2001-09
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 Bone marrow transplantation and peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy with carboplatin and cyclophosphamide followed by bone marrow and peripheral stem cell transplantation in treating patients who have advanced ovarian epithelial cancer
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy with carboplatin and cyclophosphamide followed by bone marrow and peripheral stem cell transplantation in treating patients who have advanced ovarian epithelial cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of carboplatin when combined with cyclophosphamide as high-dose therapy followed by autologous bone marrow and peripheral blood stem cell rescue in patients with platinum sensitive ovarian epithelial carcinoma II Determine the efficacy of this regimen in these patients
OUTLINE This is a dose escalation study of carboplatin Autologous bone marrow ABM is harvested on day -11 filgrastim G-CSF is administered subcutaneously SC on days -11 to -7 and autologous peripheral blood stem cells PBSC are harvested on day -6 Patients receive high dose chemotherapy comprising carboplatin IV over 15 minutes on days -5 and -4 and cyclophosphamide IV over 1 hour on days -3 and -2 PBSC are reinfused on day -1 ABM is reinfused on day 0 and G-CSF is administered SC beginning on day 7 and continuing until blood counts recover Cohorts of 2-4 patients receive escalating doses of carboplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 10 of patients experience dose-limiting toxicity A minimum of 6 patients receive carboplatin at the MTD Patients are followed at 1 month and then every 3 months for 5 years
PROJECTED ACCRUAL A minimum of 18 patients will be accrued for this study within 1 year
OUTLINE This is a dose escalation study of carboplatin Autologous bone marrow ABM is harvested on day -11 filgrastim G-CSF is administered subcutaneously SC on days -11 to -7 and autologous peripheral blood stem cells PBSC are harvested on day -6 Patients receive high dose chemotherapy comprising carboplatin IV over 15 minutes on days -5 and -4 and cyclophosphamide IV over 1 hour on days -3 and -2 PBSC are reinfused on day -1 ABM is reinfused on day 0 and G-CSF is administered SC beginning on day 7 and continuing until blood counts recover Cohorts of 2-4 patients receive escalating doses of carboplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 10 of patients experience dose-limiting toxicity A minimum of 6 patients receive carboplatin at the MTD Patients are followed at 1 month and then every 3 months for 5 years
PROJECTED ACCRUAL A minimum of 18 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| 94-08-26-05 | OTHER | JHM IRB | None |
| JHOC-9434 | OTHER | None | None |
| NCI-V94-0544 | OTHER | None | None |
| CDR0000063839 | REGISTRY | None | None |