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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedgold sodium thiomalate and gene expression analysis

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 9, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Mayo Clinic

Study sponsor

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

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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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