Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments gold sodium thiomalate, gene expression analysis, fluorine f 18 fluorothymidine, mass spectrometry, pharmacological study
Phase phase 1
Sponsor Mayo Clinic
Start date January 2007
End date September 2016
Trial size 27 participants
Trial identifier NCT00575393, 06-003532, MC0622

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

Measure
Maximum tolerated dose
time frame:
Toxicity
time frame:
Biologic activity
time frame:
Correlate PKCl expression with antitumor effects of gold sodium thiomalate
time frame:
Correlate toxicity and/or tumor response or activity with pharmacokinetic and pharmacodynamic parameters
time frame:
Anti-proliferative activity of gold sodium thiomalate by PET scan
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

Official title A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer
Principal investigator Julian Molina, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.