Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003194
Status:
TERMINATED
Last Update Posted:
2019-04-05
First Post:
2000-04-06
Brief Title:
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
Sponsor:
Seattle Childrens Hospital
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
A Phase I Study of Thiotepa in Combination With Carboplatin and Topotecan With Peripheral Blood Progenitor Cell Support for the Treatment of Children With Recurrent or Refractory Solid Tumors
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study enrollment did not meet expected goals
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 combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or refractory solid tumors
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or refractory solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of thiotepa in combination with carboplatin and topotecan with peripheral blood stem cell transplantation in patients with recurrent or refractory pediatric solid tumors
Determine the toxicity of this regimen in these patients
OUTLINE This is a dose escalation study of thiotepa
Patients may receive 2 courses of mobilization comprising cyclophosphamide and etoposide with filgrastim G-CSF support and peripheral blood stem cell PBSC collection
Patients receive thiotepa IV over 2 hours on days 0 and 1 topotecan IV over 30 minutes on days 0-4 and carboplatin IV over 2 hours on days 2 and 3 Patients also receive G-CSF beginning on day 5 24-36 hours following the last dose of topotecan PBSC are reinfused on day 6 36-48 hours following the last dose of topotecan of each course of therapy Patients receive 3 courses of therapy
Cohorts of 3-6 patients receive escalating doses of thiotepa until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 1 and 2 years
PROJECTED ACCRUAL A maximum of 24 patients will be accrued into this study
Determine the maximum tolerated dose of thiotepa in combination with carboplatin and topotecan with peripheral blood stem cell transplantation in patients with recurrent or refractory pediatric solid tumors
Determine the toxicity of this regimen in these patients
OUTLINE This is a dose escalation study of thiotepa
Patients may receive 2 courses of mobilization comprising cyclophosphamide and etoposide with filgrastim G-CSF support and peripheral blood stem cell PBSC collection
Patients receive thiotepa IV over 2 hours on days 0 and 1 topotecan IV over 30 minutes on days 0-4 and carboplatin IV over 2 hours on days 2 and 3 Patients also receive G-CSF beginning on day 5 24-36 hours following the last dose of topotecan PBSC are reinfused on day 6 36-48 hours following the last dose of topotecan of each course of therapy Patients receive 3 courses of therapy
Cohorts of 3-6 patients receive escalating doses of thiotepa until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 1 and 2 years
PROJECTED ACCRUAL A maximum of 24 patients will be accrued into this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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-G98-1373 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066029 | REGISTRY | None | None |
| FHCRC-124400 | None | None | None |