Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002948
Status:
TERMINATED
Last Update Posted:
2014-07-02
First Post:
1999-11-01
Brief Title:
High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
A Phase I Study of High Dose Topotecan With Filgrastim and Peripheral Blood Stem Cell Support for Patients With Refractory Malignancies
Status:
TERMINATED
Status Verified Date:
2014-07
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 drugs and kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of high-dose topotecan and peripheral stem cell transplantation in treating patients with refractory cancer
PURPOSE Phase I trial to study the effectiveness of high-dose topotecan and peripheral stem cell transplantation in treating patients with refractory cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose toxicities and preliminary antitumor activity of escalating doses of topotecan with filgrastim G-CSF and peripheral blood stem cell support when administered to patients with refractory malignancies for which no effective therapy exists
OUTLINE This is a dose-escalation study
Prior to stem cell harvesting patients receive 1-2 courses of mobilizing salvage chemotherapy
After stem cell harvest high-dose topotecan is administered according to an escalating dosage scale Topotecan is given over 30 minutes daily for three days A minimum of 3 patients are entered at each dose level The MTD is defined as the dose immediately below that at which 2 patients experience dose limiting toxicity
Peripheral blood stem cells PBSC are infused at least 24 hours after treatment with topotecan is complete Filgrastim G-CSF is administered subcutaneously beginning on the day PBSC are infused and continuing until blood counts recover
Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL Not specified
Determine the maximum tolerated dose toxicities and preliminary antitumor activity of escalating doses of topotecan with filgrastim G-CSF and peripheral blood stem cell support when administered to patients with refractory malignancies for which no effective therapy exists
OUTLINE This is a dose-escalation study
Prior to stem cell harvesting patients receive 1-2 courses of mobilizing salvage chemotherapy
After stem cell harvest high-dose topotecan is administered according to an escalating dosage scale Topotecan is given over 30 minutes daily for three days A minimum of 3 patients are entered at each dose level The MTD is defined as the dose immediately below that at which 2 patients experience dose limiting toxicity
Peripheral blood stem cells PBSC are infused at least 24 hours after treatment with topotecan is complete Filgrastim G-CSF is administered subcutaneously beginning on the day PBSC are infused and continuing until blood counts recover
Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL Not specified
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-G97-1155 | None | None | None |
| YALE-HIC-9042 | None | None | None |