Lung CancerPhase 1NCT00575393
Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
A Phase 1 study testing gold sodium thiomalate, gene expression analysis and fluorine F 18 fluorothymidine in people with Lung Cancer, run by Mayo Clinic at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- gold sodium thiomalate, gene expression analysis and fluorine F 18 fluorothymidine
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jan 2007to 14 Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- gold sodium thiomalate, gene expression analysis, fluorine F 18 fluorothymidine, mass spectrometry, pharmacological study
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gold sodium thiomalateDrug
gene expression analysisGenetic
fluorine F 18 fluorothymidineOther
mass spectrometryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study start25 Jan 2007
- Primary completion30 Jun 2011
- Study completion14 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian Molina, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575393
- Sponsor's protocol ID
- MC0622
- Other IDs
- MC0622, 06-003532
- Status last verified
- Oct 2018
- First submitted
- 15 Dec 2007
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00575393
- Acronym / sponsor ID
- MC0622
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Jan 2007 (actual)
- Primary completion
- 30 Jun 2011 (actual)
- Study completion
- 14 Feb 2012 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gold sodium thiomalate | Drug | – |
| gene expression analysis | Genetic | – |
| fluorine F 18 fluorothymidine | Other | – |
| mass spectrometry | Other | – |
| pharmacological study | Other | – |
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian Molina, MD, PhD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gold sodium thiomalate, gene expression analysis and fluorine F 18 fluorothymidine in people with Lung Cancer, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.