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

Completed · Phase 1

Conditions studied: Childhood Burkitt Lymphoma, Childhood Central Nervous System Germ Cell Tumor, Childhood Diffuse Large Cell Lymphoma, Childhood Grade III Lymphomatoid Granulomatosis, Childhood Immunoblastic Large Cell Lymphoma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Liver Cancer, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Childhood Medulloblastoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway Glioma, Recurrent Colon Cancer, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Melanoma, Recurrent Nasopharyngeal Cancer, Recurrent Neuroblastoma, Recurrent Osteosarcoma, Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Recurrent/Refractory Childhood Hodgkin Lymphoma, 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 irinotecan in treating young patients with refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as oxaliplatin and irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Oxaliplatin may help irinotecan kill more cancer cells by making cancer cells more sensitive to the drug. Giving oxaliplatin together with irinotecan may kill more cancer cells.

Key facts

Study ID

NCT00101270

Run by

National Cancer Institute (NCI)

People needed

24

Starts

2005-03-01

Last updated by the study team

2013-06-05

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• COG Phase I Consortium — Arcadia, California, United States

Full record on ClinicalTrials.gov

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