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:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT00659568
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed malignancy, including any of the following types:
* Renal cell
* Endometrial
* Breast
* Small cell lung carcinoma
* Lymphoma
* Metastatic or unresectable disease for which standard curative or palliative measures do not exist or are no longer effective
* Measurable disease according to RECIST criteria
* No unstable primary CNS tumors or metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
* ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
* Life expectancy \> 12 weeks
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Platelets ≥ 100 x 10\^9/L
* AST ≤ 2.5 times upper limit of normal (ULN)
* Serum creatinine ≤ ULN
* Serum bilirubin ≤ 1.5 times ULN
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to understand and willing to sign a written informed consent document
Exclusion criteria:
* Allergies to or a history of allergic reactions attributed to any other compound of similar chemical or biologic composition to temsirolimus or metformin
* Diabetes mellitus (type I or II)
* Uncontrolled hypertriglyceridemia (triglyceride levels \> 10 mmol/L)
* History of lactic acidosis
* Inability to swallow or digest oral medications
* Uncontrolled intercurrent illness including, but not limited to, any of the following:
* Uncontrolled hypertension
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness/social situation that would limit compliance with study requirements
* Significant traumatic injury within 21 days prior to treatment
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
* Recovered from all prior therapy
* At least 4 weeks since prior chemotherapy or radiotherapy (6 weeks for carmustine or mitomycin C) except low-dose, non-myelosuppressive radiotherapy
* No limitation on other prior therapy
* Concurrent low-dose anticoagulant (i.e., warfarin) allowed provided INR ≤ 1.1 times ULN
* Concurrent full-dose anticoagulant (i.e., warfarin) allowed provided INR is within institutional therapeutic range (usually 2.0-3.0)
Exclusion criteria:
* Major surgery within the past 21 days
* Prior temsirolimus (or other known inhibitors of mammalian target of rapamycin) or metformin
* Concurrent combination antiretroviral therapy for HIV-positive patients
* Concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., phenytoin, carbamazepine, or phenobarbital) or other CYP3A4 inducer (e.g., rifampin or Hypericum perforatum \[St. John's wort\])
* Concurrent investigational or commercial agents or therapies to treat the patient's malignancy
* Other concurrent investigational agents other than temsirolimus or metformin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00659568
Study Brief:
Protocol Section:
NCT00659568