Lung Cancer Clinical Trial
Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell 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.
Full 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.
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
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There are 3 Locations for this study
Scottsdale Arizona, 85259, United States
Jacksonville Florida, 32224, United States
Rochester Minnesota, 55905, United States
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