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

Lung Cancer Clinical Trial

Official title:

A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575393
• Other study ID #: MC0622
• Secondary ID: MC062206-003532
• Status: Completed
• Phase: Phase 1
• Start date: January 25, 2007
• Est. completion date: February 14, 2012

Study information

• Verified date: October 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 14, 2012
• Est. primary completion date: June 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• gold sodium thiomalate

Genetic:
• gene expression analysis

Other:
• fluorine F 18 fluorothymidine

• mass spectrometry

• pharmacological study

Locations

Country	Name	City	State
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose
Primary	Toxicity
Primary	Biologic activity
Primary	Correlate PKCl expression with antitumor effects of gold sodium thiomalate
Primary	Correlate toxicity and/or tumor response or activity with pharmacokinetic and pharmacodynamic parameters
Primary	Anti-proliferative activity of gold sodium thiomalate by PET scan