- Any solid tumor that failed standard therapy.
- Patient must have evidence for tumor by CT, MRI, PET scan, MIBG scan, serum markers,
or tissue sampling.
- Age ≤ 21 years.
- 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 ≥ 75k at least one week off platelet transfusions
- Hg≥ 8g/dL at least one week off PRBC transfusion
- AST ≤ 3 x the upper limit of normal
- ALT ≤ 3 x the upper limit of normal
- Total bilirubin ≤ 2.0 mg/dl
- 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 B-HCG pregnancy test documented within 14 days prior
to drug initiation. Females must not be breast feeding.
- Patients must be able to swallow tablets whole
- Patients must not have active infection or serious intercurrent medical illness.
- 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 EIAEDs that have been
discontinued, patients must have been off the agent for at least 2 weeks prior to