Patient eligibility
infection, tumor, allergy
TUMOR, GRAFT VERSUS HOST DISEASE, DISEASE, ALLERGY, SOLID TUMORS, INFECTION
Patients 1–18 years of age with histologically or radiographically confirmed relapsed or refractory CNS or non‐CNS solid tumors with radiographically measurable disease and no known curative therapy options were eligible. A Karnofsky/Lansky score of 50 or above was required. Prior therapy including vincristine, irinotecan, or temozolomide was permitted, however patients could not have previously received irinotecan and temozolomide in combination. Prior radiation therapy was allowed if completed greater than 14 days prior to the start of protocol therapy for local palliative radiation and greater than six months for total body or craniospinal irradiation. Patients with prior autologous or allogenic stem cell transplant were eligible if more than three months from engraftment, transfusion independent, without graft versus host disease and not taking immunosuppressive medications. Organ function requirements included an absolute neutrophil count ≥1000/mmStudy exclusions included pregnant or breast‐feeding women, prior allergy or intolerance of vincristine, irinotecan, temozolomide, or metformin, allergy to cephalosporins, or uncontrolled infection. Other exclusions included ongoing treatment with other investigational agents, other concomitant anti‐cancer agents, or hematologic growth factors. CNS tumor subjects on dexamethasone were required to be on a stable or decreasing dose for minimum seven days before enrollment.