CompletedPhase 1NCT00575393

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

StatusCompleted
PhasePhase 1
U.S. locations3
SponsorMayo Clinic
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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