Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma

Stopped early · Phase 1

Conditions studied: Angioimmunoblastic T-cell Lymphoma, B-cell Childhood Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia, Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Grade III Lymphomatoid Granulomatosis, Childhood Immunoblastic Large Cell Lymphoma, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Noncutaneous Extranodal Lymphoma, Peripheral T-cell Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent/Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Small Intestine Lymphoma, T-cell Childhood Acute Lymphoblastic Leukemia, T-cell Large Granular Lymphocyte Leukemia, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

This phase I trial is studying the side effects and best dose of oxaliplatin and etoposide in treating young patients with recurrent or refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as oxaliplatin and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Oxaliplatin may also help etoposide work better by making cancer cells more sensitive to the drug. Giving oxaliplatin together with etoposide may kill more cancer cells.

Key facts

Study ID

NCT00101205

Run by

National Cancer Institute (NCI)

People needed

40

Starts

2004-11-01

Last updated by the study team

2014-02-24

Who can join

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

You may qualify if…

• Life expectancy > 8 weeks
• Albumin > 2 g/dL
• Histologically confirmed diagnosis of 1 of the following: solid tumor; histologic verification not required for brainstem tumors or optic pathway tumors; lymphoma; recurrent or refractory to conventional therapy OR no known effective therapy exists; bone marrow involvement allowed
• Performance Status: Karnofsky >= 50 % (patients > 10 years of age) OR Lansky >= 50% (patients for =< 10 years of age)
• Absolute neutrophil count > 1,000/mm\^3
• Platelet count > 100,000/mm\^3 (transfusion independent)
• Hemoglobin > 8 g/dL (transfusion allowed)
• ALT < 5.0 times ULN
• Creatinine normal OR glomerular filtration rate >= 80 mL/min/1.73 m\^2
• Calcium normal (electrolyte supplements allowed)
• Echocardiogram and EKG normal
• Shortening fraction >= 27% OR ejection fraction > 50%
• No evidence of dyspnea at rest
• No exercise intolerance
• Pulse oximetry > 94% on room air
• Neurologic deficits due to CNS tumor must be relatively stable for >= 2 weeks before study entry
• Seizure disorder allowed provided well-controlled by non-enzyme-inducing anticonvulsants
• No peripheral neurotoxicity > grade 1
• Sodium, potassium, and magnesium normal (electrolyte supplements allowed)
• At least 1 week since prior biologic agents
• More than 1 week since prior growth factors
• More than 6 months since prior allogeneic peripheral blood stem cell transplantation AND no active graft-versus-host disease
• More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
• More than 2 weeks since prior focal radiotherapy for symptomatic metastatic sites
• More than 6 weeks since prior substantial bone marrow radiotherapy

You may not qualify if…

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No uncontrolled infection
• No history of life-threatening hypersensitivity to platinum-containing agents
• No prior oxaliplatin
• No other concurrent investigational agents
• No other concurrent anticancer therapy
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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