Anhydrovinblastine in Treating Patients With Advanced Recurrent Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003882|
Recruitment Status : Completed
First Posted : January 27, 2004
Last Update Posted : March 7, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: anhydrovinblastine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose Finding Study of Anhydrovinblastine Administered as a 1-Hour Infusion Every 3 Weeks to Patients With Advanced Solid Tumors|
|Study Start Date :||March 1999|
|Actual Primary Completion Date :||April 2000|
|Actual Study Completion Date :||September 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003882
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Nithya Ramnath, MD||Roswell Park Cancer Institute|