Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070538
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2003-10-03
Brief Title:
VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of VNP40101M And Cytarabine For Patients With Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2008-08
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 such as VNP40101M and cytarabine use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of combining VNP40101M with cytarabine in treating patients who have hematologic malignancies including myelodysplastic syndrome or relapsed refractory or untreated leukemia
PURPOSE Phase I trial to study the effectiveness of combining VNP40101M with cytarabine in treating patients who have hematologic malignancies including myelodysplastic syndrome or relapsed refractory or untreated leukemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of VP40101M when administered with cytarabine in patients with hematologic malignancies
Determine the toxic effects of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of VNP40101M
Patients receive cytarabine IV over 24 hours on days 1-4 for patients under 65 years of age OR on days 1-3 for patients 65 years of age and over Patients also receive VNP40101M IV over 15-60 minutes on day 2 Treatment repeats every 4 weeks for up to 3 courses in patients with responding disease in the absence of disease progression or unacceptable toxicity Patients with a continued response may receive additional courses at the discretion of the investigator
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Up to 10 patients may receive treatment at the MTD
PROJECTED ACCRUAL Approximately 25 patients will be accrued for this study
Determine the maximum tolerated dose of VP40101M when administered with cytarabine in patients with hematologic malignancies
Determine the toxic effects of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of VNP40101M
Patients receive cytarabine IV over 24 hours on days 1-4 for patients under 65 years of age OR on days 1-3 for patients 65 years of age and over Patients also receive VNP40101M IV over 15-60 minutes on day 2 Treatment repeats every 4 weeks for up to 3 courses in patients with responding disease in the absence of disease progression or unacceptable toxicity Patients with a continued response may receive additional courses at the discretion of the investigator
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Up to 10 patients may receive treatment at the MTD
PROJECTED ACCRUAL Approximately 25 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MDA-2003-0326 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000334879 | REGISTRY | None | None |