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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00575393 |
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Date of registration:
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15/12/2007 |
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Primary sponsor: |
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Public title:
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Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
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Scientific title:
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A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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27 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00575393 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Julian Molina, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lung Cancer
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Intervention(s)
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Drug: gold sodium thiomalate
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Genetic: gene expression analysis
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Other: 3'-deoxy-3'-[18F]fluorothymidine
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Other: mass spectrometry
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Other: pharmacological study
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Primary Outcome(s)
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Anti-proliferative activity of gold sodium thiomalate by PET scan
[Time Frame: No]
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Biologic activity
[Time Frame: No]
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Correlate PKCl expression with antitumor effects of gold sodium thiomalate
[Time Frame: No]
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Correlate toxicity and/or tumor response or activity with pharmacokinetic and pharmacodynamic parameters
[Time Frame: Yes]
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Maximum tolerated dose
[Time Frame: Yes]
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Toxicity
[Time Frame: Yes]
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Secondary ID(s)
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CDR0000579311
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MAYO-MC0622
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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