Combination Chemotherapy in Treating Young Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Childhood Central Nervous System Choriocarcinoma, Childhood Central Nervous System Embryonal Tumor, Childhood Central Nervous System Germ Cell Tumor, Childhood Central Nervous System Germinoma, Childhood Central Nervous System Mixed Germ Cell Tumor, Childhood Central Nervous System Teratoma, Childhood Central Nervous System Yolk Sac Tumor, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Central Nervous System Embryonal Tumor, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

This phase I trial is studying the side effects and best dose of oxaliplatin when given together with leucovorin and fluorouracil in treating young patients with advanced solid tumors. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Key facts

Study ID

NCT00281944

Run by

National Cancer Institute (NCI)

People needed

42

Starts

2005-09-01

Last updated by the study team

2013-05-03

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.