Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
This trial is active, not recruiting.
|Treatments||gold sodium thiomalate, gene expression analysis, fluorine f 18 fluorothymidine, mass spectrometry, pharmacological study|
|Start date||January 2007|
|End date||September 2016|
|Trial size||27 participants|
|Trial identifier||NCT00575393, 06-003532, MC0622|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
Maximum tolerated dose
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
Male or female participants from 18 years up to 120 years old.
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
|Official title||A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer|
|Principal investigator||Julian Molina, MD, PhD|
|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.|
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