Back to resultsGold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
gold sodium thiomalate
gene expression analysis
fluorine F 18 fluorothymidine
mass spectrometry
pharmacological study
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
Eligibility 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
Sites / Locations
- Mayo Clinic Scottsdale
- Mayo Clinic - Jacksonville
- Mayo Clinic Cancer Center
Outcomes
Primary Outcome Measures
Maximum tolerated dose
Toxicity
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00575393
Brief Title
Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
Official Title
A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 25, 2007 (Actual)
Primary Completion Date
June 30, 2011 (Actual)
Study Completion Date
February 14, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gold sodium thiomalate
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Other
Intervention Name(s)
fluorine F 18 fluorothymidine
Intervention Type
Other
Intervention Name(s)
mass spectrometry
Intervention Type
Other
Intervention Name(s)
pharmacological study
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Title
Toxicity
Title
Biologic activity
Title
Correlate PKCl expression with antitumor effects of gold sodium thiomalate
Title
Correlate toxicity and/or tumor response or activity with pharmacokinetic and pharmacodynamic parameters
Title
Anti-proliferative activity of gold sodium thiomalate by PET scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Molina, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
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