Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 1:09 AM
NCT ID:
NCT01529593
Eligibility Criteria:
Inclusion Criteria:
* Patients with advanced or metastatic cancer that is refractory to standard therapies, who have relapsed after standard therapy, or whose cancers have no standard therapy that induces a complete response (CR) rate of at least 10% or improves survival by at least three months
* Patients must have evaluable or measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Patients must be \>= 4 weeks beyond treatment of any chemotherapy, other investigational therapy, hormonal, biological, targeted agents or radiotherapy, and must have recovered to =\< grade 1 or previous baseline for each toxicity; exception: patients may have received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy provided pelvis, sternum, scapulae, vertebrae, or skull were not included in the radiotherapy field; patients who have received non-chemotherapeutic biological agents will need to wait at least 5 half-lives or 4 weeks (wks), whichever is shorter, from the last day of treatment; continuation of hormone replacement therapy is permitted; stable regimens of hormonal therapy i.e. for prostate cancer (e.g. leuprolide, a gonadotropin-releasing hormone \[GnRH\] agonist), ovarian, or breast cancer are not exclusionary
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
* Absolute neutrophil count \>= 1000/mL
* Platelets \>= 75,000/mL
* Creatinine \< 1.5 mg/dl in males and \< 1.4 in females
* T. Bilirubin \</= 1.5 X ULN
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and/or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2 X ULN (=\< 5 X ULN for patients with liver and/or bone metastases)
* Women of child-bearing potential MUST have a negative serum or urine pregnancy test unless prior hysterectomy or menopause (defined as 12 consecutive months without menstrual activity); patients should not become pregnant or breastfeed while on this study; sexually active patients must agree to use contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose
* Ability to understand and willingness to sign a written informed consent document
* Patients in the tumor-specific endometrial carcinoma expansion cohort that have known mutation must be willing to provide consent for biopsies
Exclusion Criteria:
* Patients who are pregnant or breastfeeding
* Uncontrolled intercurrent illness including, but not limited to, active infection requiring hospitalization
* History of hypersensitivity to temsirolimus or metformin
* History of cerebral vascular accident (CVA), myocardial infarction or unstable angina within the previous six months before starting therapy
* New York Heart Association class III or greater congestive heart failure
* Patients with major surgery within 30 days prior to entering the study
* Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs
* Patients on drugs that are strong cytochrome P450, family 3, subfamily A, polypeptide 4 (P450 CYP3A4) modifiers; these drugs should be stopped 5 half-lives prior to starting investigational agents with temsirolimus; the strong inducing or inhibiting agents should not restart until 1 week after the end of the study treatment; NOTE: we will allow replacement of steroids (with either prednisone or hydrocortisone) in patients with adrenalectomy
* Patients with a history of any grade of persistent or chronic nausea or vomiting within the last 4 weeks related to prior therapy or disease process
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT01529593
Study Brief:
Protocol Section:
NCT01529593