PKCι & mTOR Inhibition With Auranofin+Sirolimus for Squamous Cell Lung Cancer

Overview

  • Study type

    Interventional
  • Study phase

    I/II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 11-001987
    NCT ID: NCT01737502
    Sponsor Protocol Number: MC1125

About this study

The primary purpose of this study is to find out what effects (good or bad) the drugs auranofin and sirolimus have on patients with lung cancer; to find out if auranofin and sirolimus can stop or slow the growth of the lung cancer; to learn more about how auranafin and sirolimus work against lung cancer by testing blood and tissue samples.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Histologic or cytologic confirmation of lung cancer (squamous, Rasmutated adenocarcinoma or small cell lung cancer) Patients must have received at least one course of chemotherapy consisting of a platinum doublet and must have no acceptable standard treatment options.
  • Prior radiation therapy is permitted as long as:
    • Recovered from the toxic effects of radiation treatment before study entry, except for alopecia
  • Absolute neutrophil count (ANC) ≥ 1500 uL
  • Platelets (PLT) ≥ 100,000 uL
  • Hemoglobin (Hgb) ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or direct bilirubin ≤ ULN
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) ≤ 3 x ULN or SGOT (AST) and SGPT (ALT) ≤ 5 x ULN is acceptable if liver has tumor involvement
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
  • Negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
  • Ability to provide informed consent
  • Life expectancy ≥ 12 weeks
  • Willing to return to Mayo Clinic enrolling institution for follow-up
  • Willing to provide tissue and blood samples for correlative research purposes

Exclusion Criteria:

Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:

  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception Symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases or seizure disorder; NOTE: Patients with treated CNS metastases without evidence of progression and without uncontrolled symptoms or need for steroids may enroll Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded because of possible pharmacokinetic interactions with oral investigational agents Unwilling or unable to, comply with the protocol

Any of the following prior therapies:

  • Radiation to ≥ 25% of bone marrow
  • Major surgery (i.e., laparotomy), open biopsy, or significant traumatic injury ≤ 4 weeks prior to registration; minor surgery ≤ 2 weeks prior to registration; insertion of a vascular access device is not considered major or minor surgery in this regard

Any of the following concurrent severe and/or uncontrolled medical conditions:

  • Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication
  • Angina pectoris
  • History of congestive heart failure ≤ 84 days (3 months), unless ejection fraction > 40%
  • Myocardial infarction ≤ 168 days (6 months) prior to registration
  • Cardiac arrhythmia
  • Poorly controlled diabetes
  • Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • Active or recent history of hemoptysis; if hemoptysis has resolved with measures such as palliative radiation therapy (e.g. 3000 cGy over 10 fractions), arteriographic embolization or endobronchial interventions (e.g. photodynamic therapy, brachytherapy), etc. for > 14 days, patients may be considered for participation in this study
  • > grade 2 hypertriglyceridemia
  • ≥ grade 2 hypercholesterolemia
  • Any illness that in the opinion of the investigator would compromise the ability of the patient to participate safely in the clinical trial.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Helen Ross, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20115754

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