Lung Cancer
Conditions
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
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.
Interventions
GENETICgene expression analysis
OTHERmass spectrometry
OTHERpharmacological study
Sponsors
Mayo Clinic
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose | — |
| Toxicity | — |
| Biologic activity | — |
| 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 | — |
Countries
United States
Outcome results
None listed