Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cance… (NCT01737502) | Clinical Trial Compass
CompletedPhase 1/2
Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer
United States29 participantsStarted 2014-05-14
Plain-language summary
This phase I/II trial studies the side effects and best dose of auranofin when given together with sirolimus and to see how well it works in treating patients with lung cancer that has spread or other places in the body and cannot be cured or controlled by treatment or has come back after a period of time during which the cancer could not be detected. Auranofin and sirolimus may stop or slow the growth of lung cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologic or cytologic confirmation of lung cancer (squamous, ras-mutated 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 samples for correlative research purposes
Exclusion Criteria:
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Symptomatic, untr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Phase 1 Patients Experiencing a DLT
Timeframe: 28 days
2
Number Phase 1 Patients Experiencing a Grade 3+ AE