Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002977
Status:
COMPLETED
Last Update Posted:
2010-09-15
First Post:
1999-11-01
Brief Title:
Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase I Trial of Melphalan and Thiotepa Followed by Autologous or Syngeneic Peripheral Blood Stem Cell PBSC Rescue in Patients With a Complete Response Following Standard Therapy for Stage IIIIV Epithelial 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 drugs and kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of melphalan and thiotepa followed by peripheral stem cell transplantation in treating patients with stage III or stage IV epithelial ovarian cancer in complete remission
PURPOSE Phase I trial to study the effectiveness of melphalan and thiotepa followed by peripheral stem cell transplantation in treating patients with stage III or stage IV epithelial ovarian cancer in complete remission
Detailed Description:
OBJECTIVES I Assess the toxic effects of combined high dose melphalan and thiotepa chemotherapy followed by stem cell rescue in patients with stage III or IV ovarian epithelial cancer in complete remission II Determine the maximum tolerated dose of thiotepa that can be given with melphalan in these patients III Evaluate the interpatient blood level variability and pharmacokinetics of melphalan given intravenously
OUTLINE This is a dose escalation study of thiotepa Patients receive cytoreduction and mobilization of peripheral blood stem cells PBSC with filgrastim G-CSF and cyclophosphamidepaclitaxel cyclophosphamideetoposide or cyclophosphamideetoposidecisplatin within 30-90 days of last dose of standard therapy PBSC are then collected Patients then receive melphalan IV over 30 minutes on days -6 and -5 and thiotepa IV over 2 hours on days -4 and -3 PBSC are reinfused on day 0 G-CSF is administered on days 0-21 Cohorts of 5-15 patients each receive escalating doses of thiotepa until the maximum tolerated dose MTD is reached The MTD is determined as the dose at which 2-5 of 4-15 patients experience dose limiting toxicity Patients are followed at 100 days then at 6 12 and 24 months
PROJECTED ACCRUAL A total of 30-45 patients will be accrued for this study over 2 years
OUTLINE This is a dose escalation study of thiotepa Patients receive cytoreduction and mobilization of peripheral blood stem cells PBSC with filgrastim G-CSF and cyclophosphamidepaclitaxel cyclophosphamideetoposide or cyclophosphamideetoposidecisplatin within 30-90 days of last dose of standard therapy PBSC are then collected Patients then receive melphalan IV over 30 minutes on days -6 and -5 and thiotepa IV over 2 hours on days -4 and -3 PBSC are reinfused on day 0 G-CSF is administered on days 0-21 Cohorts of 5-15 patients each receive escalating doses of thiotepa until the maximum tolerated dose MTD is reached The MTD is determined as the dose at which 2-5 of 4-15 patients experience dose limiting toxicity Patients are followed at 100 days then at 6 12 and 24 months
PROJECTED ACCRUAL A total of 30-45 patients will be accrued for this study over 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 |
|---|---|---|---|
| CDR0000065499 | REGISTRY | PDQ | None |
| 118100 | None | None | None |
| NCI-G97-1229 | None | None | None |