Perifosine With Temsirolimus for Recurrent Pediatric Solid Tumors

Inclusion criteria

• Any solid tumor that has failed standard therapy
• Patient must have evidence of tumor by CT, MRI, MIBG scan, serum markers, or tissue sampling.
• Age ≤ 21 years (age ≤ 35 years for biopsy proven medulloblastoma or neuroblastoma)
• Karnofsky/Lansky performance status ≥ 50% (Karnofsky score for age> 16 years and Lansky score for age ≤ 16 years)
• ANC≥ 1000 at least 24 hours off GCSF
• Platelets ≥ 100K at least one week off platelet transfusions
• Hg≥ 8g/dL at least one week off PRBC transfusion
• AST ≤ 2 x the upper limit of normal
• ALT ≤ 2 x the upper limit of normal
• Total bilirubin ≤ 2.0 mg/dl
• Patients must have cholesterol level < 350 mg/dl and triglycerides level < 400 mg/dl because temsirolimus can induce hyperlipidemia.
• Serum creatinine ≤ 1.5 x the upper limit of normal for age, or calculated creatinine clearance or nuclear GFR ≥ 70 ml/min/1.73 m2.
• ≥ 3 weeks since last non-nitrosourea chemotherapy
• ≥ 6 weeks since last nitrosoureas
• ≥ 4 weeks since last RT
• Patients must agree to practice adequate contraception. Females of childbearing potential must have a negative serum B-HCG pregnancy test documented within 14 days prior to registration. Females must not be breast feeding.
• Patients must be able to swallow tablets whole
• Patients that participated in the phase I single agent perifosine study for recurrent pediatric solid tumors and did not experience a DLT are eligible to participate in this study and can start ≥ 2 weeks since last dose of perifosine
• Patients that have been previously treated with an mTOR inhibitor can still enroll in this trial as long as they did not experience a DLT in the single agent mTOR inhibitor trial

Exclusion criteria

• Pregnancy
• Patients must not have an uncontrolled active infection.
• HIV-Positive patients receiving combination anti-retroviral therapy are excluded from the study due to possible retro-viral drug interactions. HIV testing not required.
• Patients must not be taking EIAEDs. If patients were previously on EIAEDs that have been discontinued, patients must have been off the agent for at least 2 weeks prior to registration.
• History of or known pulmonary hypertension or history of or known pneumonitis.