Metformin Hydrochloride, Vincristine Sulfate, Irinotecan Hydrochloride, and Temozolomide in Treating Younger Patients with Relapsed or Refractory Solid Tumors

Inclusion Criteria

• Patients have a histologically or radiographically confirmed relapsed or refractory solid tumor or primary central nervous system (CNS) malignancy
• Patients must have radiographically measurable disease
• Patients must have relapsed or refractory cancers for which there is no known curative option or other available therapy proven to prolong survival with an acceptable quality of life
• Karnofsky >= 50% for patients > 16 years old, and Lansky >= 50 for patients 1-16 years old
• Patients may have received prior therapy including vincristine, irinotecan, or temozolomide; patients may not have previously been treated with combination therapy of irinotecan and temozolomide * Patients must be fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study ** Patients must not have received myelosuppressive chemotherapy within 3 weeks of starting protocol therapy, or a minimum of six weeks must have elapsed since prior nitrosourea chemotherapy ** At least 7 days must have elapsed since the last administration of filgrastim, or 14 days since administration of pegfilgrastim ** At least 7 must have elapsed since the last administration of any biologic agent ** At least 14 days since the last dose of local palliative radiation therapy; greater than 6 months must have elapsed since the last day of treatment if given total body irradiation, craniospinal irradiation ** Complete resolution of graft versus host disease and no current need for immunosuppressive medication; greater than 3 months must have elapsed since engraftment and no longer requiring transfusion of platelets or injection of colony stimulating factors
• Peripheral absolute neutrophil count (ANC) >= 1000/uL
• Platelet count >= 100,000/uL (no platelet transfusion within 7 days prior to obtaining laboratory result)
• Hemoglobin >= 8.0 gm/dL
• Creatinine clearance or glomerular filtration rate >= 70 ml/min/1.73 m^2 (calculated or measured as appropriate for age and level of concern by treating medical doctor [MD])
• Total bilirubin =< 1.5 x upper limit of normal (ULN) for age * Temozolomide should not be administered if total bilirubin is > 2.0 mg/dl or SGPT(ALT) > 2.5 x ULN
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 x ULN * Temozolomide should not be administered if total bilirubin is > 2.0 mg/dl or SGPT(ALT) > 2.5 x ULN
• Serum albumin >= 2 gm/dL
• All patients >= 18 years of age must sign a written informed consent; for patients < 18 years old, the patient’s parents or legal guardians must sign a written informed consent, unless the patient is an emancipated minor; childhood assent, when age appropriate as per institutional guidelines, should be signed by the participating patient

Exclusion Criteria

• Significant organ dysfunction, not meeting inclusion criteria
• Pregnant or breast-feeding woman will not be entered on this study
• Concomitant medications: * Growth factors that support platelet or white cell number of function must not have been administered within the past 7 days * Patients with CNS tumors who have not been on a stable or decreasing dose of dexamethasone for the past 7 days * Patients who are currently receiving another investigational drug * Patients who are currently receiving other anti-cancer agents * Allergy or intolerance to agents on this protocol: vincristine, irinotecan, temozolomide, or metformin * Allergy to cephalosporins * Patients who have uncontrolled infection, positive blood cultures within the past 48 hours, or receiving treatment for Clostridium difficile infection