Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
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.
Checked against the public recordLast updated Oct 9, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Mayo Clinic
- Interventions being studied
- Drug: gold sodium thiomalate; Genetic: gene expression analysis; Other: fluorine F 18 fluorothymidine; Other: mass spectrometry; Other: pharmacological study
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic ScottsdaleScottsdale, Arizona
- Mayo Clinic - JacksonvilleJacksonville, Florida
- Mayo Clinic Cancer CenterRochester, Minnesota
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 9, 2018. Always confirm current availability with the study team.