Anhydrovinblastine in Treating Patients With Advanced Recurrent Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00003882
- Lead Sponsor
- Roswell Park Cancer Institute
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States