Clinical Trial: Chemotherapy and Stem Cell Transplantation in Treating Children with Central Nervous System Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: Roswell Park Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
central nervous system cancer
childhood brain tumor
hematopoietic and lymphoid cancer
Neuroblastoma
Retinoblastoma
 Drug: carboplatin
 Drug: etoposide
 Drug: filgrastim
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
 Procedure: peripheral blood stem cell transplantation
Phase I

MedlinePlus related topics:  Brain Cancer;   Cancer;   Cancer Alternative Therapy;   Eye Cancer;   Neuroblastoma;   Neurologic Diseases
Genetics Home Reference related topics:  retinoblastoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of High-Dose Carboplatin With Autologous Stem Cell Support and Etoposide in Pediatric Patients With Primary Central Nervous System Malignancies

Further Study Details: 

OBJECTIVES:

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.

Eligibility

Ages Eligible for Study:  up to  18 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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
  • 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

Endocrine therapy

  • Not specified

Radiotherapy

Surgery

  • Not specified

Location Information


Missouri
      St. Louis Children's Hospital, Saint Louis,  Missouri,  63110,  United States

New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Barbara Jean Bambach, MD,  Study Chair,  Roswell Park Cancer Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000269284; RPCI-DS-00-03
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  January 27, 2003
ClinicalTrials.gov Identifier:  NCT00053118
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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