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

NCT ID: NCT00575393

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-25
• Study Completion Date: 2012-02-14

Brief 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.

Detailed Description

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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

gold sodium thiomalate

Intervention Type: DRUG

gene expression analysis

Intervention Type: GENETIC

fluorine F 18 fluorothymidine

Intervention Type: OTHER

mass spectrometry

Intervention Type: OTHER

pharmacological study

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian Molina, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

MC0622

Identifier Type: OTHER

Identifier Source: secondary_id

06-003532

Identifier Type: OTHER

Identifier Source: secondary_id

MC0622

Identifier Type: -

Identifier Source: org_study_id