Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: gold sodium thiomalate (Drug); gene expression analysis (Genetic); fluorine F 18 fluorothymidine (Other); mass spectrometry (Other); pharmacological study (Other)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): Julian Molina, MD, PhD, Principal Investigator, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer
Study design: Primary Purpose: Treatment
Primary outcome: Maximum tolerated doseToxicity Biologic activity Correlate PKCl expression with antitumor effects of gold sodium thiomalate Correlate toxicity and/or tumor response or activity with pharmacokinetic and pharmacodynamic parameters Anti-proliferative activity of gold sodium thiomalate by PET scan
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Mayo Clinic Scottsdale, Scottsdale, Arizona 85259-5499, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida 32224, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: January 2007
Last updated: March 31, 2015
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