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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Oxaliplatin

Criteria

Inclusion Criteria:

• 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

• More than 3 months since prior craniospinal (> 24 Gy), whole pelvis, or total-body radiotherapy

• Recovered from all prior therapy

• No concurrent enzyme-inducing anticonvulsants, including, but not limited to, the following: Barbiturates; Phenytoin; Carbamazepine

Exclusion Criteria:

• 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.