T138067 Sodium in Treating Patients With Advanced Refractory Cancer
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 T138067 sodium in treating patients with advanced refractory cancer.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: batabulin sodium||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Dose Escalation Study to Evaluate the Safety of T138067-Sodium in Patients With Advanced Refractory Cancer|
|Study Start Date:||April 1998|
|Study Completion Date:||January 2001|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the maximum tolerated dose of T138067 sodium that can be given to patients with advanced refractory cancer on a 28-day schedule and establish a dose for further study. II. Evaluate the safety and dose limiting toxicity of T138067 sodium in these patients. III. Determine the pharmacokinetic parameters after a single intravenous dose of this agent in these patients. IV. Obtain safety data and preliminary efficacy information after repetition of single doses of T138067 sodium in these patients.
OUTLINE: This is an open label, dose escalation study. Patients receive T138067 sodium by IV over 3 hours. Patients may be retreated every 4 weeks for up to 6 courses (6 months total) in the absence of disease progression or dose limiting toxicity (DLT). At least 3 patients are treated at each dose level in the absence of DLT. The maximum tolerated dose is defined as the dose level where 2 of 3-6 patients experience DLT.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued into this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003359
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||David R. Spriggs, MD||Memorial Sloan Kettering Cancer Center|