Clinical Trial Details
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NCT02149459 : Treatment of Recurrent Brain Tumors: Metabolic Manipulation Combined With Radiotherapy
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Willingness and ability to participate in diet/metformin intervention for the 8 week

- 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 ß-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

- 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

- ß-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
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