NCT00575393

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1 lung-cancer

Timeline
Completed

Started Jan 2007

Typical duration for phase_1 lung-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2012

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

4.4 years

First QC Date

December 15, 2007

Last Update Submit

October 4, 2018

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (6)

  • 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

Interventions

gold sodium thiomalateDRUG
gene expression analysisGENETIC
fluorine F 18 fluorothymidineOTHER
mass spectrometryOTHER
pharmacological studyOTHER

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Gold Sodium ThiomalateGene Expression ProfilingalovudineMass Spectrometry

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

ThiomalatesMalatesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsOrganogold CompoundsOrganometallic CompoundsSulfhydryl CompoundsSulfur CompoundsGenetic TechniquesInvestigative TechniquesChemistry Techniques, Analytical

Study Officials

  • Julian Molina, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2007

First Posted

December 18, 2007

Study Start

January 25, 2007

Primary Completion

June 30, 2011

Study Completion

February 14, 2012

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

US(3)