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Recurrent Non-small Cell Lung CancerPhase 1NCT01383668

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

A Phase 1 study testing sirolimus, gold sodium thiomalate and pharmacological study in people with Recurrent Non-small Cell Lung Cancer and Squamous Cell Lung Cancer, run by Mayo Clinic.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase I trial studies the side effects and best dose of sirolimus and gold sodium thiomalate when given together in treating patients with advanced squamous non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sirolimus, gold sodium thiomalate and pharmacological study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2011to 8 Feb 2013
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cohort I (Dose Escalation) only: must have histologic proof of an advanced, solid tumor that is now unresectable
  • Cohort II (MTD) only
  • Patients must have platinum-refractory NSCLC (platinum-refractory defined as either disease progression either during or within 6 months of completion of first-line platinum-based chemotherapy)
  • Must have measurable disease
  • Must have received at least one prior approved chemotherapeutic regimen unless there is no known, approved therapeutic regimen for their malignancy
  • Must have evidence of disease progression within the preceding 6 months - Absolute neutrophil count (ANC) >= 1500/uL
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  • Platelets (PLT) >= 100,000/uL
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • (Serum glutamic oxaloacetic transaminase [SGOT]) aspartate aminotransferase (AST) / (serum glutamic pyruvic transaminase [SGPT]) alanine transaminase (ALT) =< 3 x ULN or (SGOT) AST / (SGPT) ALT =< 5 x ULN if liver involvement
  • Creatinine =< 1.5 x ULN
  • Fasting blood glucose =< 126 mg/dL
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
  • Ability to provide informed consent
  • Willingness to return to Mayo Clinic in Florida for follow-up
  • Life expectancy >= 84 days (3 months)
  • Willing to provide blood and tissue samples for correlative research purposes; Note: the goals of this study include assessment of the biologic effects of the agent being tested and are, therefore, contingent upon availability of the biologic specimens
  • Women of childbearing potential only: negative (serum) pregnancy test done =< 7 days prior to registration

Who cannot join

  • Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Any of the following prior therapies:
  • Chemotherapy =< 28 days prior to registration
  • Mitomycin C/nitrosoureas =< 42 days prior to registration
  • Immunotherapy =< 28 days prior to registration
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  • Biologic therapy =< 28 days prior to registration
  • Radiation therapy =< 28 days prior to registration
  • Radiation to > 25% of bone marrow
  • Bevacizumab =< 28 days prior to registration
  • Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
  • New York Heart Association classification III or IV
  • Known central nervous system (CNS) metastases or seizure disorder; patients with known brain metastases that have been successfully treated and stable for >= 6 months without requirement for corticosteroids and without seizure activity will be eligible
  • Patients with known diabetes mellitus unless well-controlled (fasting blood sugar [FBS] =< 126mg/dL and hemoglobin [Hb]A1C =< 7.0)
  • Receiving therapeutic anticoagulation with warfarin; NOTE: prophylactic anticoagulation (i.e., low dose warfarin) of venous or arterial access devices is allowed, provided that International Normalized Ratio (INR) < 1.5; therapeutic anti-coagulation with low molecular weight heparin is allowed at time of registration
  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception - Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation)
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Cohort II Only: other active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, patient must not be receiving other cytotoxic or molecularly targeted therapeutics treatment for their cancer; patients receiving certain hormonal manipulations as part of their treatment may be allowed to continue at the discretion of the principal investigator (PI) (e.g. luteinizing hormone-releasing hormone [LHRH] analogs for prostate cancer); concurrent endocrine therapy for breast cancer will not be permitted
  • History of myocardial infarction =< 168 days (6 months) or congestive heart failure requiring use of ongoing maintenance therapy for life threatening ventricular arrhythmias
  • Known allergy to ATM (Aurothiomalate [gold sodium thiomalate]) or other gold compounds
  • >= Grade 2 hypertriglyceridemia
  • >= Grade 2 hypercholesterolemia

About this study

Official title: Combined PKCiota and mTOR Inhibition for Treatment of Advanced Squamous Lung Cancer

This phase I trial studies the side effects and best dose of sirolimus and gold sodium thiomalate when given together in treating patients with advanced squamous non-small cell lung cancer (NSCLC). Sirolimus and gold sodium thiomalate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Read the detailed description

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of ATM (gold sodium thiomalate) plus sirolimus. SECONDARY OBJECTIVES: I. To describe the adverse event profile associated with this treatment combination. II. To preliminarily evaluate the response rate, time to progression, progression-free survival and overall survival of patients treated with this treatment combination. TERTIARY OBJECTIVES: I. To evaluate tumor biomarkers of protein kinase C (PKCι) and mammalian Target Of Rapamycin (mTOR) signaling activity as predictors of response to ATM/sirolimus therapy. II. To evaluate the use of surrogate biomarkers of PKCι and mTOR inhibition in peripheral blood lymphocytes (PBLs) to monitor response to ATM/sirolimus therapy. OUTLINE: This is a dose-escalation study. Patients receive sirolimus orally (PO) once daily (QD) on days 1-28 and gold sodium thiomalate intramuscularly (IM) on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 months.

Being tested
sirolimus, gold sodium thiomalate, pharmacological study, RNA analysis, polymerase chain reaction
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sirolimusDrug

    Also called AY 22989, Rapamune, rapamycin, SLM

    Given PO

  • gold sodium thiomalateDrug

    Also called Aurolate, Myochrysine, sodium aurothiomalate

    Given IM

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • RNA analysisGenetic

    Correlative studies

  • polymerase chain reactionGenetic

    Also called PCR

    Correlative studies

Study groups in NCT01383668
Study groupRoleWhat they receive
Treatment (enzyme inhibitor therapy)ExperimentalPatients receive sirolimus PO QD on days 1-28 and gold sodium thiomalate IM on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: sirolimus; Drug: gold sodium thiomalate; Other: pharmacological study; Genetic: RNA analysis; Genetic: polymerase chain reaction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximally tolerated dose (MTD) of ATM plus sirolimus

    MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.

    Measured: 28 days

Secondary outcomes (5)

  1. To describe the adverse event profile associated with the treatment combination of ATM plus sirolimus.

    Measured: Up to 3 months after completion of study treatment

  2. Confirmed response rate

    Measured: Every 6 weeks

  3. Overall survival time

    Measured: Up to 3 months after completion of study treatment

  4. Progression-free survival (PFS)

    Measured: Up to 3 months after completion of study treatment

  5. Time-to-progression (TTP)

    Measured: Up to 3 months after completion of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completion8 Feb 2013
  4. Study completion8 Feb 2013

Why it stopped: lack of access to study drug

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01383668
Sponsor's protocol ID
MC102A
Other IDs
NCI-2011-00968
Status last verified
Dec 2012
First submitted
24 Jun 2011
Last updated
1 Apr 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing sirolimus, gold sodium thiomalate and pharmacological study in people with Recurrent Non-small Cell Lung Cancer and Squamous Cell Lung Cancer, run by Mayo Clinic.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 24 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Maximally tolerated dose (MTD) of ATM plus sirolimus (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01383668.

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 1 Apr 2020.

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