Oxaliplatin and Irinotecan in Treating Young Patients With Refractory Solid Tumors or Lymphomas
Childhood Burkitt Lymphoma, Childhood Central Nervous System Germ Cell Tumor, Childhood Diffuse Large Cell Lymphoma
About this trial
This is an interventional treatment trial for Childhood Burkitt Lymphoma
Eligibility Criteria
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)
Sites / Locations
- COG Phase I Consortium
Arms of the Study
Arm 1
Experimental
Treatment (irinotecan hydrochloride, oxaliplatin)
Patients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.