Lymphoma Clinical Trial
Official title:
High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining chemotherapy with peripheral stem cell
transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill
more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with peripheral
stem cell transplantation in treating children who have central nervous system cancer.
Status | Completed |
Enrollment | 1 |
Est. completion date | July 2004 |
Est. primary completion date | July 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 18 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed primary central nervous system malignancy - Recurrent, persistent, or progressive disease after at least 1 prior first-line treatment regimen PATIENT CHARACTERISTICS: Age - 18 and under at initial diagnosis Performance status - ECOG 0-2 Life expectancy - At least 8 weeks Hematopoietic - Absolute neutrophil count greater than 750/mm^3 - WBC greater than 2,500/mm^3 - Platelet count greater than 100,000/mm^3 - No underlying myelodysplasia, stem cell disorder, or other inherent hematologic synthetic defect Hepatic - Liver function tests less than 2 times normal OR - Absence of active hepatitis by liver biopsy - Bilirubin less than 1.5 mg/dL Renal - Glomerular filtration rate greater than 60 mL/min by radionucleotide assay Cardiovascular - Ejection fraction at least 45% Pulmonary - Clinically normal pulmonary function (patients 5 years of age and under) - FEV_1 and FVC at least 50% (patients over 5 years of age) OR - Arterial blood gas normal and DLCO greater than 50% Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No mucositis or mucosal infection - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 3 weeks since prior systemic cytotoxic chemotherapy Endocrine therapy - Not specified Radiotherapy - At least 6 months since prior radiotherapy to the pelvis or spine Surgery - Not specified |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | St. Louis Children's Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute |
United States,
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