Vorinostat With or Without Isotretinoin in Treating Young Patients With Recurrent or Refractory Solid Tumors, Lymphoma, or Leukemia

Inclusion Criteria:

• Histologically confirmed* diagnosis of 1 of the following:

  • Recurrent or refractory solid tumor or lymphoma (for patients in group 1)

    • Measurable or evaluable disease

  • Recurrent or refractory leukemia (for patients in group 2)

    • Greater than 25% blasts in the bone marrow (i.e., M3 bone marrow)
    • Active extramedullary disease allowed except leptomeningeal disease

  • Recurrent or refractory CNS tumor of 1 of the following types (for patients in group 3):

    • Neuroblastoma
    • Medulloblastoma/CNS primitive neuroectodermal tumor
    • Atypical teratoid rhabdoid tumor
• No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
• No bone marrow involvement by disease (for patients in groups 1 and 3)
• No active CNS leukemia
• Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
• Performance status - Karnofsky 60-100% (for patients > 10 years of age)
• Absolute neutrophil count ≥ 1,000/mm^3 (for solid tumor patients)
• Platelet count ≥ 100,000/mm^3* (for solid tumor patients) (20,000/mm^3** for leukemia patients)
• Hemoglobin ≥ 8.0 g/dL (RBC transfusion allowed) (for solid tumor and leukemia patients)
• Triglycerides < 300 mg/dL (for patients in group 3)
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT ≤ 5 times ULN
• Albumin ≥ 2 g/dL
• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min

• Creatinine based on age as follows:

  • No greater than 0.8 mg/dL (for patients ≤ 5 years of age)
  • No greater than 1.0 mg/dL (for patients 6 to 10 years of age)
  • No greater than 1.2 mg/dL (for patients 11 to 15 years of age)
  • No greater than 1.5 mg/dL (for patients over 15 years of age)
• Negative dipstick for protein OR < 1,000 mg protein/24 hour urine collection (for patients in group 3)
• No evidence of gross hematuria (for patients in group 3)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Body surface area ≥ 0.5 m^2
• Neurologic deficits in patients with CNS tumors must be stable for ≥ 1 week before study entry
• Able to swallow whole capsules
• No uncontrolled infection
• Skin toxicity < grade 1 (for patients in group 3)
• Recovered from prior immunotherapy
• At least 7 days since prior hematopoietic growth factors
• At least 7 days since prior antineoplastic biologic agents

• At least 2 months since prior stem cell transplantation or rescue

  • No evidence of active graft-versus-host disease
• No other concurrent biologic therapy or immunotherapy
• More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
• No concurrent chemotherapy
• Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for ≥ 7 days prior to study entry
• No concurrent dexamethasone for antinausea or antiemetic therapy
• Recovered from prior radiotherapy
• At least 2 weeks since prior local, palliative, small-port radiotherapy
• At least 3 months since prior total-body irradiation, radiotherapy to the craniospinal area, or radiotherapy to ≥ 50% of the pelvis
• At least 6 weeks since other prior substantial radiotherapy to the bone marrow
• No concurrent radiotherapy
• At least 2 weeks since prior valproic acid
• No other concurrent investigational agents
• No other concurrent anticancer therapy
• No concurrent enzyme-inducing anticonvulsants