Talotrexin in Treating Young Patients With Recurrent Solid Tumors or Leukemia That is Recurrent or Does Not Respond to Treatment

DISEASE CHARACTERISTICS:

• Diagnosis of either of the following:

  • Recurrent solid tumor

    • Histologically confirmed* malignancy at original diagnosis or relapse
    • Measurable or evaluable disease

    • Lymphoma or primary CNS tumor allowed

      • Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for the past 7 days

  • Recurrent or refractory leukemia

    • Confirmed relapse, as defined by M3 marrow (25% blasts in bone marrow aspirate or biopsy)
    • Active extramedullary disease allowed provided there is no leptomeningeal involvement NOTE: *Histological confirmation not required for intrinsic brain stem tumors

• Bone marrow metastases allowed

  • Not refractory to red blood cell or platelet transfusion
• No pleural effusion or significant ascites
• No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
• No Down syndrome

PATIENT CHARACTERISTICS:

• Karnofsky performance status (PS) 50-100% (for patients > 10 years of age) OR Lansky PS 50-100% (for patients ≤ 10 years of age)
• Absolute neutrophil count ≥ 1,000/mm³ (for patients with solid tumors without bone marrow involvement)
• Platelet count ≥ 100,000/mm³ (transfusion independent)
• Hemoglobin ≥ 8.0 g/dL

• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine adjusted according to age as follows:

  • No greater than 0.6 mg/dL (1 year to 23 months)
  • No greater than 0.8 mg/dL (2 to 5 years)
  • No greater than 1.0 mg/dL (6 to 9 years)
  • No greater than 1.2 mg/dL (10 to 12 years)
  • No greater than 1.4 mg/dL (13 years and over [female])
  • No greater than 1.5 mg/dL (13 to 15 years [male])
  • No greater than 1.7 mg/dL (16 years and over [male])
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT ≤ 110 U/L (ULN is 45 U/L)
• Albumin ≥ 2 g/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No uncontrolled infection
• No known condition that, in the opinion of the investigator, would preclude study compliance

PRIOR CONCURRENT THERAPY:

• Recovered from all prior treatment-related toxicity
• At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) (for patients with solid tumors)
• At least 24 hours since prior cytoreduction therapy initiated with hydroxyurea (for patients with leukemia)
• At least 2 weeks since prior local palliative radiotherapy (small port)
• At least 6 months since prior total-body irradiation (TBI), craniospinal radiotherapy, or ≥ 50% radiotherapy to the pelvis
• At least 6 weeks since prior substantial bone marrow radiotherapy

• At least 3 months since prior stem cell transplant or rescue without TBI

  • No evidence of active graft-versus-host disease
• At least 7 days since prior growth factor therapy
• At least 7 days since prior biological therapy
• No nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, penicillins, sulfa drugs (bactrim, septra), ciprofloxacin, tetracycline, thiaxide diuretics, or probenecid within 2 days prior to, during, or within 5 days after treatment with talotrexin
• No long-acting NSAIDs (e.g., nabumetone, naproxen, oxaprozin, piroxicam) within 5 days prior to, during, or within 5 days after treatment with talotrexin
• No concurrent investigational drugs
• No concurrent anticancer agents or therapy (e.g., chemotherapy, radiotherapy, immunotherapy, or biologic therapy)