Combination Chemotherapy in Treating Young Patients With Advanced Solid Tumors
Childhood Central Nervous System Choriocarcinoma, Childhood Central Nervous System Embryonal Tumor, Childhood Central Nervous System Germ Cell Tumor
About this trial
This is an interventional treatment trial for Childhood Central Nervous System Choriocarcinoma
Eligibility Criteria
Inclusion Criteria: Histologically diagnosed malignant solid tumor, including tumors of the CNS, that has progressed despite standard therapy or for which no effective standard therapy is known Patients with brainstem glioma or intrinsic pontine glioma do not need biopsy proof of the diagnosis if imaging studies are consistent with the diagnosis Measurable or nonmeasurable disease No pleural effusion or ascites causing respiratory compromise (≥ grade 2 dyspnea) ECOG performance status (PS) 0-2 for patients ≥ 16 years of age Karnofsky PS ≥ 40% for patients > 10 years of age Lansky Play Scale ≥ 40% for patients ≤ 10 years of age Peripheral absolute neutrophil count (ANC) ≥ 1,000/mm^3 Platelet count ≥ 75,000/mm^3 (transfusion independent) Hemoglobin ≥ 8.5 g/dL (transfusion permitted) Serum creatinine ≤ 1.5 times upper limit of normal (ULN) Creatinine clearance OR radioisotope glomerular filtration rate > 60mL/min Total bilirubin < 1.5 mg/dL ALT and AST ≤ 2.5 times ULN (5 times ULN if liver involvement with primary tumor) Ejection fraction ≥ 50% OR shortening fraction ≥ 28% Life expectancy of > 8 weeks No radiological evidence of pulmonary fibrosis, interstitial pneumonia, or extensive and symptomatic interstitial fibrosis of the lung Room air oxygen saturation ≥ 90% at altitudes ≥ 5,000 feet OR ≥ 93% at altitudes < 5,000 feet DLCO > 50% of predicted (for patients who received prior bleomycin and are able to comply with pulmonary function testing) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reactions attributed to compounds of similar chemical or biologic composition to platinum or oxaliplatin as well as other agents used in study treatment No other serious or poorly controlled social circumstance, psychiatric illness, or medical condition including, but not limited to, the following: ongoing or active infection, uncontrolled seizure disorder, uncontrolled symptomatic congestive heart failure, or cardiac arrhythmia that could be exacerbated by or complicate compliance with study therapy No HIV-positive patients Recovered from prior therapy No persistent toxicities from previous therapies ≥ grade 2 Stable grade 3 neurotoxicity is allowed in patients with CNS tumors only who have a baseline neurotoxicity due to primary tumor involvement or postoperative complications At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) At least 4 weeks since prior local radiotherapy (small port) At least 6 months since prior craniospinal irradiation, irradiation to ≥ 50% of the pelvis, or other substantial bone marrow irradiation, including total body irradiation No previous treatment with oxaliplatin At least 14 days since prior biological therapy (including monoclonalantibody therapy) At least 7 days since prior retinoids, sargramostim (GM-CSF), or filgrastim (G-CSF) At least 14 days since prior pegfilgrastim No concurrent pegfilgrastim or GM-CSF Patients requiring steroids should be on stable or decreasing dose for ≥ 7 days prior to study entry, and must not be on more than 4 mg of dexamethasone (or equivalent) per day At least 4 weeks since prior major surgical procedure Simple surgical procedures, including biopsy or central line placement or similar procedure, are allowed within 4 weeks of study entry if the patient has recovered to baseline At least 3 months since prior autologous or allogeneic stem cell transplantation No concurrent immunosuppressive therapy No evidence of ongoing graft versus host disease (GVHD) No concurrent use of other investigational agents No other concurrent anticancer therapies or agents No other concurrent chemotherapy, radiation therapy, or herbal medications or supplements
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (oxaliplatin, leucovorin calcium, fluorouracil)
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.