High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies
N/A
18 Years
Both
Brain and Central Nervous System Tumors, Lymphoma, Neuroblastoma, Retinoblastoma
Trial Information
High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies
OBJECTIVES:
- Determine the feasibility of administering an outpatient protocol comprising high-dose
carboplatin with autologous stem cell support and etoposide in pediatric patients with
primary central nervous system malignancies.
- Determine the maximum tolerated dose of carboplatin when administered in this regimen
in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is dose-escalation study of carboplatin.
Patients receive filgrastim (G-CSF) IV once daily for 6 days followed by a maximum of 5
apheresis sessions. If the target number of peripheral blood stem cells is not achieved,
some patients receive G-CSF and undergo apheresis as above after a 2-week rest.
At least 3 days after completion of G-CSF, patients receive high-dose carboplatin IV over 1
hour on day 1, stem cell reinfusion on day 3, G-CSF subcutaneously on days 4-18 and 43-61,
and oral etoposide 3 times daily on days 21-42. Treatment continues for a maximum of 4
courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 1 year and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-15 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Barbara Jean Bambach, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000269284
NCT ID:
NCT00053118
Start Date:
March 2002
Completion Date:
July 2004
Related Keywords:
- Brain and Central Nervous System Tumors
- Lymphoma
- Neuroblastoma
- Retinoblastoma
- childhood central nervous system germ cell tumor
- childhood choroid plexus tumor
- childhood craniopharyngioma
- childhood grade I meningioma
- childhood grade II meningioma
- childhood grade III meningioma
- recurrent childhood brain stem glioma
- recurrent childhood cerebellar astrocytoma
- recurrent childhood cerebral astrocytoma
- recurrent childhood ependymoma
- recurrent childhood medulloblastoma
- recurrent childhood supratentorial primitive neuroectodermal tumor
- recurrent neuroblastoma
- recurrent retinoblastoma
- childhood visual pathway and hypothalamic glioma
- childhood atypical teratoid/rhabdoid tumor
- primary central nervous system non-Hodgkin lymphoma
- Lymphoma
- Nervous System Neoplasms
- Neuroblastoma
- Retinoblastoma
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| St. Louis Children's Hospital | Saint Louis, Missouri 63110 |
