Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003080
Status:
COMPLETED
Last Update Posted:
2010-09-15
First Post:
1999-11-01
Brief Title:
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Persistent or Platinum Refractory Stage III or IV Ovarian Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase I Trial of Sequential High Dose Chemotherapy Regimens Followed by Autologous or Syngeneic Peripheral Blood Stem Cell PBSC Rescue in Patients With Persistent Stage IIIIV Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2010-09
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 Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of sequential chemotherapy followed by peripheral stem cell transplantation in treating patients with persistent or platinum refractory stage III or stage IV ovarian cancer
PURPOSE Phase I trial to study the effectiveness of sequential chemotherapy followed by peripheral stem cell transplantation in treating patients with persistent or platinum refractory stage III or stage IV ovarian cancer
Detailed Description:
OBJECTIVES I Establish the feasibility of treating patients with persistent or platinum refractory stage III or IV ovarian cancer with sequential high dose chemotherapy followed by peripheral blood stem cell rescue II Determine the maximum tolerated dose of thiotepa that can be given in such approach
OUTLINE This is a dose escalating study of thiotepa Initial cytoreduction and mobilization of peripheral blood stem cells PBSC are conducted with FHCRC protocol 5063 cyclophosphamide and paclitaxel or 5063 cyclophosphamide and etoposide PBSC from syngeneic twins are collected according to FHCRC protocol 7530 Patients then undergo leukapheresis Patients with remaining bulky disease greater than 2 cm after cytoreductionmobilization may undergo surgical debulking High dose chemotherapy begins 30-40 days after the last chemotherapy in the cytoreductionmobilization regimen Patients receive mitoxantrone IV infusion over 15 minutes on days -7 and -5 Thiotepa IV is administered on days -4 and -3 Peripheral blood stem cell PBSC infusion occurs on day 0 60-90 days later melphalan IV is administered over 60 minutes on day -3 Patients undergo PBSC infusion on day 0 Patients are entered in cohorts of 3 In the absence of dose-limiting toxicity DLT subsequent cohorts of 3 patients each receive escalating doses of thiotepa on the same schedule If DLT is observed in 2 of 3 patients then the next cohort of patients each receive treatment at the next lower dose level Once 12 patients are treated at a particular dose level then this dose is declared the maximum tolerated dose After engraftment following melphalan patients receive oral tamoxifen twice a day for up to 5 years or until relapse Patients are followed every 3 months for the first year every 6 months for the next 4 years then annually
PROJECTED ACCRUAL 20-30 patients will be accrued in 2 years
OUTLINE This is a dose escalating study of thiotepa Initial cytoreduction and mobilization of peripheral blood stem cells PBSC are conducted with FHCRC protocol 5063 cyclophosphamide and paclitaxel or 5063 cyclophosphamide and etoposide PBSC from syngeneic twins are collected according to FHCRC protocol 7530 Patients then undergo leukapheresis Patients with remaining bulky disease greater than 2 cm after cytoreductionmobilization may undergo surgical debulking High dose chemotherapy begins 30-40 days after the last chemotherapy in the cytoreductionmobilization regimen Patients receive mitoxantrone IV infusion over 15 minutes on days -7 and -5 Thiotepa IV is administered on days -4 and -3 Peripheral blood stem cell PBSC infusion occurs on day 0 60-90 days later melphalan IV is administered over 60 minutes on day -3 Patients undergo PBSC infusion on day 0 Patients are entered in cohorts of 3 In the absence of dose-limiting toxicity DLT subsequent cohorts of 3 patients each receive escalating doses of thiotepa on the same schedule If DLT is observed in 2 of 3 patients then the next cohort of patients each receive treatment at the next lower dose level Once 12 patients are treated at a particular dose level then this dose is declared the maximum tolerated dose After engraftment following melphalan patients receive oral tamoxifen twice a day for up to 5 years or until relapse Patients are followed every 3 months for the first year every 6 months for the next 4 years then annually
PROJECTED ACCRUAL 20-30 patients will be accrued in 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 |
|---|---|---|---|
| CDR0000065775 | REGISTRY | PDQ | None |
| FHCRC-114400 | None | None | None |
| NCI-G97-1329 | None | None | None |