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

October 4, 2018 updated by: Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5499
        • Mayo Clinic Scottsdale
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Jacksonville
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Maximum tolerated dose
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Julian Molina, MD, PhD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2007

Primary Completion (Actual)

June 30, 2011

Study Completion (Actual)

February 14, 2012

Study Registration Dates

First Submitted

December 15, 2007

First Submitted That Met QC Criteria

December 15, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC0622 (Other Identifier: Mayo Clinic Cancer Center)
  • 06-003532 (Other Identifier: Mayo Clinic IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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