Spots Global Cancer Trial Database for 3-AP in Treating Patients With Advanced or Metastatic Solid Tumors

Study Description

Brief Summary: This phase I trial is studying the side effects and best dose of 3-AP in treating patients with advanced or metastatic solid tumors. 3-AP may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description: OBJECTIVES: I. Determine the safety, tolerability, and toxicity of oral 3-AP in patients with advanced solid tumors. II. Determine the maximum tolerated dose and recommended phase II dose of this drug in these patients. III. Determine the oral bioavailability and pharmacokinetics of this drug. IV. Assess tumoral expression of genes involved in response and resistance to 3-AP. V. Observe and record any tumor response in these patients. OUTLINE: This is a multicenter, dose-escalation study. Patients receive a one time dose of 3-AP IV over 2 hours on day -7. Patients then receive oral 3-AP twice daily on days 1-3, 8-10, and 15-17. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oral 3-AP until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Blood samples for pharmacokinetic analysis are collected periodically over 8 hours after the IV dose of 3-AP and after the first oral dose of 3-AP during course 1. After completion of study treatment, patients are followed periodically.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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