Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00575393
- Lead Sponsor
- Mayo Clinic
- Brief Summary
RATIONALE: Gold sodium thiomalate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of gold sodium thiomalate in treating patients with advanced non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
* To determine the maximum tolerated dose of gold sodium thiomalate in patients with advanced non-small cell lung cancer.
* To describe the toxicities associated with this treatment.
* To describe any preliminary evidence of biologic activity.
* To further assess the correlation between PKCι expression and the antitumor effects of gold sodium thiomalate.
* To study the association of clinical (toxicity and/or tumor response or activity) with pharmacokinetic/pharmacodynamic parameters.
* To describe anti-proliferative activity of gold sodium thiomalate through 3-deoxy-3-\[\^18F\]-fluorothymidine positron emission tomography imaging.
OUTLINE: This is a dose-escalation study of gold sodium thiomalate.
Patients receive gold sodium thiomalate intramuscularly on days 1, 8, 15 and 22. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive gold sodium thiomalate once every 4 weeks until a total cumulative dose of 1 gram is delivered.
Blood samples are collected at baseline and prior to therapy in weeks 3, 5, 7, 9, and 11. Samples are analyzed by mass spectometry for pharmacokinetics. Paraffin-embedded tumor tissue samples are analyzed for PKC_l expression and antitumor activity. Antiproliferative effects of gold sodium thiomalate are analyzed by 3-deoxy-3-\[\^18F\]-fluorothymidine positron emission tomography imaging.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biologic activity Maximum tolerated dose Toxicity Correlate PKCl expression with antitumor effects of gold sodium thiomalate Correlate toxicity and/or tumor response or activity with pharmacokinetic and pharmacodynamic parameters Anti-proliferative activity of gold sodium thiomalate by PET scan
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States