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

• Status: Completed
• Trial end date: 2012-02-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Gold Sodium Thiomalate

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