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

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer

Intervention: gold sodium thiomalate (Drug); gene expression analysis (Genetic); fluorine F 18 fluorothymidine (Other); mass spectrometry (Other); pharmacological study (Other)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Julian Molina, MD, PhD, Principal Investigator, Affiliation: Mayo Clinic

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.

Clinical Details

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

Study design: Primary Purpose: Treatment

Primary outcome:

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Mayo Clinic Scottsdale, Scottsdale, Arizona 85259-5499, United States

Mayo Clinic - Jacksonville, Jacksonville, Florida 32224, United States

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

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2007
Last updated: March 31, 2015

Page last updated: August 23, 2015

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