Status:
TERMINATED
Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Angioimmunoblastic T-cell Lymphoma
B-cell Childhood Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of oxaliplatin and etoposide in pediatric patients with recurrent or refractory solid tumors or lymphoma. II. Determine the dose-limiting ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00101205
Start Date
November 1 2004
Last Update
February 24 2014
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105