Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors

DISEASE CHARACTERISTICS:

• Histologically confirmed* malignant solid tumor, including brain tumor, at original diagnosis or relapse

  • Refractory disease NOTE: *Histologic confirmation not required for intrinsic brain stem tumors
• Measurable or evaluable disease
• No known curative therapy OR therapy proven to prolong survival with an acceptable quality of life exists
• No known bone marrow metastases

PATIENT CHARACTERISTICS:

Age

• 1 to 21

Performance status

• Lansky 50-100% (for patients ≤ 10 years of age)
• Karnofsky 50-100% (for patients > 10 years of age)

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm^3
• Platelet count ≥ 100,000/mm^3 (transfusion independent)
• Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed)

Hepatic

• ALT ≤ 110 U/L (upper limit of normal [ULN] for ALT is 45 U/L)
• Bilirubin ≤ 1.5 times ULN
• Albumin ≥ 2 g/dL

Renal

• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR

• 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 > 15 years of age)

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Neurologic deficits in patients with CNS tumors must be stable for ≥ 1 week prior to study entry
• No uncontrolled infection
• No documented allergy to cephalosporins or dacarbazine

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Recovered from prior immunotherapy

• At least 3 months since prior stem cell transplantation or rescue without total-body irradiation

  • No evidence of active graft-versus-host disease
• At least 7 days since prior antineoplastic biologic agents
• At least 7 days since prior hematopoietic growth factors
• No concurrent biologic therapy or immunotherapy
• No concurrent prophylactic filgrastim (G-CSF) during the first course of study treatment

Chemotherapy

• Recovered from prior chemotherapy

• Prior temozolomide, vincristine, irinotecan, or topotecan allowed

  • No prior coadministration of temozolomide and irinotecan
  • No disease progression during treatment with either irinotecan or temozolomide
• More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
• No other concurrent chemotherapy

Endocrine therapy

• Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for ≥ 7 days prior to study entry

Radiotherapy

• Recovered from prior radiotherapy
• At least 6 months since prior total-body irradiation, craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis
• At least 6 weeks since other prior substantial bone marrow radiotherapy
• At least 2 weeks since prior local palliative radiotherapy (small port)
• No concurrent radiotherapy

Surgery

• Not specified

Other

• No other concurrent investigational drugs
• No other concurrent anticancer therapy

• No concurrent enzyme-inducing anticonvulsants, including any of the following:

  • Phenobarbital
  • Phenytoin
  • Carbamazepine
  • Oxcarbazepine

• No concurrent administration of any of the following:

  • Rifampin
  • Voriconazole
  • Itraconazole
  • Ketoconazole
  • Aprepitant
  • Hypericum perforatum (St. John's wort)
• No concurrent treatment for clostridium difficile infection