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 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT02149459
Eligibility Criteria:
Inclusion Criteria:
* Willingness and ability to participate in diet/metformin intervention for the 8 week period.
* Patients must have a previously histologically or cytologically confirmed glioma (astrocytic or oligodendroglial supratentorial tumors grades 2, 3 or 4 according to the WHO 2007 classification 82) that has been previously treated with fractionated radiation therapy and now shows evidence of recurrence. There is no limit regarding the number / type of previous therapies that the patient has received for glioma, aside from exceptions mentioned below. If the brain tumor is in an eloquent location (e.g. brain stem) a clinical diagnosis is sufficient.
* Patients must have recovered from the toxic effects of prior therapy.
* Patients must have recovered from the effects of any prior surgery to any part of the body. There must be a minimum of 10 days from the day of surgery to the day of registration. For core or needle biopsy, a minimum of 7 days must have elapsed prior to registration.
* Patients may have previously undergone more than one craniotomy.
* Prior treatment with cytotoxic and biological agents is permissible. There should be at least a 2 week break between prior treatment and enrollment.
* Prior treatment with fractionated radiation therapy (up to 66Gy) is an eligibility criterion, however this should have been completed ≥ 4 weeks prior to enrollment.
* One prior single fraction radio-surgical procedure within the treatment field is acceptable if V12\<5cc (V12 is the volume of brain receiving 12 or more Gy). Additional radio-surgical procedures outside of the treatment area are acceptable.
* Age \>=18 years.
* ECOG performance status \<2 (Karnofsky\>60%).
* Life expectancy of greater than 2 months.
* Patients must have normal organ and marrow function as defined below:
* -leukocytes \>2,000/mcL
* -absolute neutrophil count \>1,200/mcL
* -platelets \>80,000/mcL
* -AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
* No contra-indications of metformin use:
* Metformin allergy
* Renal failure, creatinine levels over 150 μmol/l (1.7 mg/dL)
* Liver disease
* Current alcohol abuse
* Women of childbearing potential must have a negative β-HCG pregnancy test documented within 14 days of registration.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Known to suffer from one of the following metabolic disorders (all rare):
* Carnitine deficiency (primary)
* Carnitine palmitoyltransferase (CPT) I or II deficiency
* Carnitine translocase deficiency
* β-oxidation defects
* Medium-chain acyldehydrogenase deficiency (MCAD)
* Long-chain acyl dehydrogenase deficiency (LCAD)
* Short-chain acyl dehydrogenase deficiency (SCAD)
* Long-chain 3-hydroxyacyl-CoA deficiency
* Medium-chain 3-hydroxyacyl-CoA deficiency.
* Pyruvate carboxylase deficiency
* Porphyria
* Patients receiving insulin or oral medication on a daily basis for diabetes mellitus
* Known severe dyslipidemia: total cholesterol \>400 mg/dl, LDL cholesterol \> 300 mg/dl, triglycerides \> 500 mg/dl
* Contraindications to metformin use:
* Metformin allergy
* Renal failure: creatinine levels over 150 μmol/l (1.7 mg/dL)
* Liver disease
* Current alcohol abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02149459
Study Brief:
Protocol Section:
NCT02149459