Spots Global Cancer Trial Database for Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer

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Trial Identification

Brief Title: Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer

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

Study ID: NCT00575393

Conditions

Lung Cancer

Interventions

gold sodium thiomalate

gene expression analysis

fluorine F 18 fluorothymidine

mass spectrometry

pharmacological study

Study Description

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.