Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004036
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-12-10
Brief Title:
Combination Chemotherapy Plus Amifostine in Treating Patients With Advanced Cancer
Sponsor:
The Cleveland Clinic
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of High Dose Chemotherapy Using Amifostine for In-Vivo Protection of GM-CSF Primed Progenitor Cells
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 tumors from dividing so they stop growing or die Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Phase I trial to study the effectiveness of amifostine plus combination chemotherapy in treating patients with advanced cancer
PURPOSE Phase I trial to study the effectiveness of amifostine plus combination chemotherapy in treating patients with advanced cancer
Detailed Description:
OBJECTIVES I Determine the effects of priming on the granulocyte and thrombocyte nadirs produced by high dose cyclophosphamide and carboplatin in patients with advanced malignancies II Determine the effects of amifostine on the granulocyte and thrombocyte nadirs produced by this same regimen when administered with sargramostim primed progenitor cells III Determine the maximum tolerated dose of cyclophosphamide and carboplatin that can be administered with sargramostim primed progenitor cells
OUTLINE This is a dose escalation study Patients receive intravenous amifostine over 10 minutes on day 0 followed by intravenous cyclophosphamide and carboplatin consecutively over 5-15 minutes Sargramostim is administered subcutaneously on days -7 to -2 and again beginning on day 1 until absolute neutrophil count is appropriate Course is repeated every 28 days until disease progression or unacceptable toxic effects are observed Nonresponding patients discontinue treatment after 2 courses Patients are treated for a maximum of 6 courses Groups of 3-6 patients receive escalating doses of cyclophosphamide and carboplatin until the maximum tolerated dose MTD is determined If dose limiting toxicity DLT occurs in 2 of 6 patients at a given dose level then dose escalation ceases and the next lower dose is declared the MTD
PROJECTED ACCRUAL Approximately 24-30 patients will be accrued for this study within 1 year
OUTLINE This is a dose escalation study Patients receive intravenous amifostine over 10 minutes on day 0 followed by intravenous cyclophosphamide and carboplatin consecutively over 5-15 minutes Sargramostim is administered subcutaneously on days -7 to -2 and again beginning on day 1 until absolute neutrophil count is appropriate Course is repeated every 28 days until disease progression or unacceptable toxic effects are observed Nonresponding patients discontinue treatment after 2 courses Patients are treated for a maximum of 6 courses Groups of 3-6 patients receive escalating doses of cyclophosphamide and carboplatin until the maximum tolerated dose MTD is determined If dose limiting toxicity DLT occurs in 2 of 6 patients at a given dose level then dose escalation ceases and the next lower dose is declared the MTD
PROJECTED ACCRUAL Approximately 24-30 patients will be accrued for this study within 1 year
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-V98-1424 | None | None | None |
| CCF-IRB-1907 | None | None | None |
| IMMUNEX-001G9701 | None | None | None |