Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025129
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2001-10-11
Brief Title:
VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of VNP4010M A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer
Status:
COMPLETED
Status Verified Date:
2004-03
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 cancer cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of VNP40101M in treating patients who have advanced solid tumors or lymphomas
PURPOSE Phase I trial to study the effectiveness of VNP40101M in treating patients who have advanced solid tumors or lymphomas
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of VNP40101M in patients with advanced solid tumors or lymphomas
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the anti-tumor effects of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive VNP40101M IV over 15 minutes on day 1 Treatment repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose MTD is determined The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose-limiting toxicity
PROJECTED ACCRUAL Approximately 20-30 patients will be accrued for this study
Determine the maximum tolerated dose of VNP40101M in patients with advanced solid tumors or lymphomas
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the anti-tumor effects of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive VNP40101M IV over 15 minutes on day 1 Treatment repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose MTD is determined The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose-limiting toxicity
PROJECTED ACCRUAL Approximately 20-30 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 |
|---|---|---|---|
| NCI-V01-1669 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068919 | REGISTRY | None | None |