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

Mayo Clinic17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Lung Cancer

Interventions

gold sodium thiomalateDRUG

gene expression analysisGENETIC

fluorine F 18 fluorothymidineOTHER

mass spectrometryOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (3)

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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