View Clinical Trial (Medical Research Study)
A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer
| City: |
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Jacksonville |
| State: |
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Florida |
| Zip Code: |
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32224 |
| Conditions: |
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Lung Cancer |
| Purpose: |
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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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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00575393 |
| Primary Contact: |
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Principal Investigator
Julian Molina, MD, PhD
Mayo Clinic
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| Backup Contact: |
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N/A |
| Location Contact: |
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Jacksonville, Florida 32224
United States
Clinical Trials Office - All Mayo Clinic Locations
Phone: 507-538-7623
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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