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| ID | Type | Description | Link |
|---|---|---|---|
| MC0622 | Other Identifier | Mayo Clinic Cancer Center | |
| 06-003532 | Other Identifier | Mayo Clinic IRB |
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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.
OBJECTIVES:
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gold sodium thiomalate | Drug | |||
| gene expression analysis | Genetic | |||
| fluorine F 18 fluorothymidine | Other | |||
| mass spectrometry | Other | |||
| pharmacological study | Other |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Julian Molina, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | United States | ||
| Mayo Clinic - Jacksonville |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D006052 | Gold Sodium Thiomalate |
| D020869 | Gene Expression Profiling |
| C002854 | alovudine |
| D013058 | Mass Spectrometry |
| ID | Term |
|---|---|
| D013870 | Thiomalates |
| D008293 | Malates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
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| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D050607 | Organogold Compounds |
| D009942 | Organometallic Compounds |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D002623 | Chemistry Techniques, Analytical |