Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Mayo Clinic National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00575393

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: gold sodium thiomalate Genetic: gene expression analysis Other: 3'-deoxy-3'-[18F]fluorothymidine Other: mass spectrometry Other: pharmacological study	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Gold Sodium Thiomalate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose [ Designated as safety issue: Yes ]
Toxicity [ Designated as safety issue: Yes ]
Biologic activity [ Designated as safety issue: No ]
Correlate PKCl expression with antitumor effects of gold sodium thiomalate [ Designated as safety issue: No ]
Correlate toxicity and/or tumor response or activity with pharmacokinetic and pharmacodynamic parameters [ Designated as safety issue: Yes ]
Anti-proliferative activity of gold sodium thiomalate by PET scan [ Designated as safety issue: No ]

Estimated Enrollment:	27
Study Start Date:	January 2007
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575393

Locations

United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Julian Molina, MD, PhD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000579311, MAYO-MC0622
Study First Received:	December 15, 2007
Last Updated:	August 8, 2009
ClinicalTrials.gov Identifier:	NCT00575393 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Antirheumatic Agents

Gold Sodium Thiomalate
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Gold Sodium Thiomalate
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Antirheumatic Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009