Phase I Study of Perifosine With Temsirolimus for Recurrent Pediatric Solid Tumors
- Any solid tumor that has failed standard therapy
- Patient must have evidence of tumor by CT, MRI, MIBG scan, serum markers, or tissue
- 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
- 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
- History of or known pulmonary hypertension or history of or known pneumonitis.