Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003703
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Advanced Solid Tumors
Sponsor:
Jewish General Hospital
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I and Pharmacokinetics Study of SarCNU in Patients With Advanced Cancers
Status:
COMPLETED
Status Verified Date:
2002-09
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
PURPOSE Phase I trial to study the effectiveness of chemotherapy using sarCNU in patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of chemotherapy using sarCNU in patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of SarCNU in patients with advanced solid malignancies II Determine the toxic effects of SarCNU in these patients III Characterize the pharmacokinetic profile of this regimen in these patients IV Determine any evidence of antineoplastic activity of this regimen in these patients
OUTLINE This is a dose-escalation study Patients receive oral SarCNU on days 1 5 and 9 Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of SarCNU 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 Once the MTD is determined additional patients are treated at the MTD
PROJECTED ACCRUAL Approximately 12-36 patients will be accrued for this study
OUTLINE This is a dose-escalation study Patients receive oral SarCNU on days 1 5 and 9 Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of SarCNU 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 Once the MTD is determined additional patients are treated at the MTD
PROJECTED ACCRUAL Approximately 12-36 patients will be accrued for this study
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 |
|---|---|---|---|
| JGH-CR97097 | None | None | None |
| CR-97-0917 | None | None | None |
| CR9809NI | None | None | None |
| NCI-T98-0015 | None | None | None |