Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002950
Status:
COMPLETED
Last Update Posted:
2020-08-17
First Post:
1999-11-01
Brief Title:
Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Phase III Study of Topotecan SKF 104864 With Recombinant GM-CSF Sargramostim Used as a Priming Agent in Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2020-08
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 Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase III trial to study the effectiveness of topotecan plus sargramostim in treating patients who have advanced cancer
PURPOSE Phase III trial to study the effectiveness of topotecan plus sargramostim in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES I Identify a priming schedule of sargramostim GM-CSF that reduces the percentage of progenitor cells in cycle at the time of chemotherapy administration in patients with advanced malignancies II Determine the maximum tolerated dose and toxic effects of topotecan when administered with sargramostim in these patients III Conduct a preliminary assessment of the activity of this topotecan regimen in these patients
OUTLINE This is a dose escalation study of topotecan Patients receive priming with sargramostim GM-CSF on days -4 through -2 On day 0 topotecan IV is administered over 30 minutes Cohorts of 6 patients receive escalating doses of topotecan The maximum tolerated dose MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity DLT Sargramostim resumes on day 1 following topotecan and continues for 5 days or until sufficient hematologic recovery The next course of topotecan is given 48 hours later Treatment repeats every 6 weeks for 4 courses Patients are followed every 3 months for the first year then every 6 months thereafter
PROJECTED ACCRUAL 15-25 patients will be accrued for the duration of 18 months
OUTLINE This is a dose escalation study of topotecan Patients receive priming with sargramostim GM-CSF on days -4 through -2 On day 0 topotecan IV is administered over 30 minutes Cohorts of 6 patients receive escalating doses of topotecan The maximum tolerated dose MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity DLT Sargramostim resumes on day 1 following topotecan and continues for 5 days or until sufficient hematologic recovery The next course of topotecan is given 48 hours later Treatment repeats every 6 weeks for 4 courses Patients are followed every 3 months for the first year then every 6 months thereafter
PROJECTED ACCRUAL 15-25 patients will be accrued for the duration of 18 months
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-G97-1158 | OTHER_GRANT | NCI | None |
| YALE-HIC-9043 | OTHER | None | None |