Oxaliplatin and Irinotecan in Treating Young Patients With Refractory Solid Tumors or Lymphomas

Inclusion Criteria:

• Histologically confirmed refractory malignant solid tumor or lymphoma

  • Intrinsic brain stem tumors and optic pathway tumors do not require histologic verification
• No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists

• Measurable or evaluable disease

  • Evaluable disease is defined as a tumor that cannot be measured using a ruler or calipers, but can be assessed to determine disease progression or complete response, such as any of the following:

    • Positive lesions on metaiodobenzylguanidine (MIBG) or bone scan
    • Metastatic bone marrow disease
    • Elevated tumor markers
    • Presence of a malignant pleural effusion
• No leukemia
• Performance status - Karnofsky 50-100% (for patients > 10 years of age)
• Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
• Not specified
• Absolute neutrophil count ≥ 1,000/mm^3
• Platelet count ≥ 100,000/mm^3 (transfusion independent)
• Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
• 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 age 5 and under)
  • No greater than 1.0 mg/dL (for patients age 6 to 10)
  • No greater than 1.2 mg/dL (for patients age 11 to 15)
  • No greater than 1.5 mg/dL (for patients age 16 and over)
• No arrhythmia on EKG
• No evidence of dyspnea at rest
• No exercise intolerance
• Pulse oximetry > 94% on room air and no evidence of pulmonary fibrosis by chest radiograph* or CT scan
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• Weight ≥ 10 kg
• Neurologic deficits relatively stable for ≥ 1 week before study entry (patients with CNS tumors only)
• No electrolyte (e.g., sodium, potassium, bicarbonate, calcium, magnesium, and phosphate) abnormality ≥ grade 2 (electrolyte supplementation allowed)
• No uncontrolled infection
• No history of life-threatening allergy to camptothecin derivatives or platinum agents
• No sensory or motor peripheral neuropathy ≥ grade 2
• No elevation of amylase or lipase ≥ grade 2
• Able to tolerate enteral medications (e.g., cefixime, cefpodoxime, or loperamide)
• Recovered from all prior immunotherapy
• At least 7 days since prior hematopoietic growth factors
• At least 7 days since prior antineoplastic biologic therapy
• Prior stem cell transplantation or rescue without total-body irradiation (TBI) allowed provided ≥ 3 months have elapsed and there is no evidence of active graft-versus-host disease
• No concurrent immunotherapy
• No concurrent biologic therapy
• More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
• No prior oxaliplatin
• No other concurrent chemotherapy
• Concurrent steroids allowed provided dose has been stable for ≥ 7 days before study entry
• See Biologic therapy
• Recovered from all prior radiotherapy
• At least 2 weeks since prior local palliative small port radiotherapy
• At least 6 months since prior TBI
• At least 6 months since prior craniospinal, whole spinal, or whole lung/abdominal radiotherapy
• At least 6 months since prior radiotherapy to ≥ 50 % of the pelvis
• At least 6 weeks since other prior substantial radiotherapy to the bone marrow
• No concurrent radiotherapy
• No other concurrent investigational drugs
• No other concurrent anticancer therapy
• No concurrent cephalosporin antibiotics

• No concurrent use of any of the following:

  • Phenytoin
  • Carbamazepine
  • Oxcarbazepine
  • Barbiturates
  • Rifampin
  • Phenobarbital
  • Azole antifungal agents
  • Aprepitant
  • Hypericum perforatum (St. John's wort)