Lung Cancer Clinical Trial
Official title:
A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer
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.
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 PKCĪ¹ 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.
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