Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003882
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
1999-11-01
Brief Title:
Anhydrovinblastine in Treating Patients With Advanced Recurrent Solid Tumors
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Phase I Dose Finding Study of Anhydrovinblastine Administered as a 1-Hour Infusion Every 3 Weeks to Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2011-03
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 tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of anhydrovinblastine in treating patients who have advanced recurrent solid tumors
PURPOSE Phase I trial to study the effectiveness of anhydrovinblastine in treating patients who have advanced recurrent solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and assess the toxicity of anhydrovinblastine in patients with advanced refractory solid tumors II Assess the safety pharmacokinetics and efficacy of this treatment regimen in this patient population
OUTLINE This is a dose escalation study Patients receive anhydrovinblastine IV over 1 hour on day 1 Courses are repeated every 3 weeks Treatment continues in the absence of disease progression or unacceptable toxicity The dose of anhydrovinblastine is escalated in cohorts of 1-6 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose that at which no more than 2 of 6 patients experience dose limiting toxicity Patients are followed at 1 month after treatment and then monthly until death
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study within 8 months
OUTLINE This is a dose escalation study Patients receive anhydrovinblastine IV over 1 hour on day 1 Courses are repeated every 3 weeks Treatment continues in the absence of disease progression or unacceptable toxicity The dose of anhydrovinblastine is escalated in cohorts of 1-6 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose that at which no more than 2 of 6 patients experience dose limiting toxicity Patients are followed at 1 month after treatment and then monthly until death
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study within 8 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 |
|---|---|---|---|
| RPCI-DS-9844 | None | None | None |