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High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies

Phase 1
18 Years
Not Enrolling
Brain and Central Nervous System Tumors, Lymphoma, Neuroblastoma, Retinoblastoma

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Trial Information

High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies


- 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


- Histologically confirmed primary central nervous system malignancy

- Recurrent, persistent, or progressive disease after at least 1 prior first-line
treatment regimen



- 18 and under at initial diagnosis

Performance status

- ECOG 0-2

Life expectancy

- At least 8 weeks


- 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


- Liver function tests less than 2 times normal OR

- Absence of active hepatitis by liver biopsy

- Bilirubin less than 1.5 mg/dL


- Glomerular filtration rate greater than 60 mL/min by radionucleotide assay


- Ejection fraction at least 45%


- 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%


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No mucositis or mucosal infection

- HIV negative


Biologic therapy

- Not specified


- At least 3 weeks since prior systemic cytotoxic chemotherapy

Endocrine therapy

- Not specified


- At least 6 months since prior radiotherapy to the pelvis or spine


- Not specified

Type of Study:


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


United States: Food and Drug Administration

Study ID:




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



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