gold sodium thiomalate in treating patients with advanced non-small cell lung cancer

Conditions: Lung Cancer

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.

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.

Eligibility criteria:
disease characteristics: * histologically confirmed advanced non-small cell lung cancer * no known standard therapy for disease that is potentially curative or definitely capable of extending life expectancy * no symptomatic or worsening cns metastases despite optimal therapy patient characteristics: * ecog performance status 0-2 * life expectancy ≥ 12 weeks * anc ≥ 1,500/µl * platelet count ≥ 100,000/µl * total bilirubin ≤ 2 times upper limit of normal (uln) * ast ≤ 3 times uln (5 times uln if liver involvement) * creatinine ≤ 1.2 times uln * hemoglobin ≥ 9.0 g/dl * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * must be willing to provide blood and tissue samples * no uncontrolled infection * no new york heart association class iii or iv heart disease * no known allergy to gold sodium thiomalate prior concurrent therapy: * recovered from acute, reversible effects of prior chemotherapy regardless of interval since last treatment * no prior chemotherapy within the past 3 weeks * no prior mitomycin c or nitrosoureas within the past 6 weeks * no prior immunotherapy within the past 3 weeks * no prior biologic therapy within the past 3 weeks * no prior radiotherapy within the past 3 weeks * no prior radiotherapy to \> 25% of bone marrow * no other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (i.e., utilized for a non-fda-approved indication and in the context of a research investigation) * no concurrent prophylactic colony stimulating factors

Keywords: stage iiib non-small cell lung cancer stage iv non-small cell lung cancer recurrent non-small cell lung cancer