Chemotherapy and Stem Cell Transplantation in Treating Children With Central Nervous System Cancer

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00053118
First received: January 27, 2003
Last updated: February 25, 2011
Last verified: February 2011
  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 Intervention Phase
Brain and Central Nervous System Tumors
Lymphoma
Neuroblastoma
Retinoblastoma
Biological: filgrastim
Drug: carboplatin
Drug: etoposide
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Enrollment: 1
Study Start Date: March 2002
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: filgrastim
    IV
    Drug: carboplatin
    IV
    Drug: etoposide
    IV
    Procedure: bone marrow ablation with stem cell support
    IV
    Procedure: peripheral blood stem cell transplantation
    IV
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053118

Locations
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Study Chair: Barbara Jean Bambach, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Bambach, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00053118     History of Changes
Other Study ID Numbers: CDR0000269284, RPCI-DS-00-03
Study First Received: January 27, 2003
Last Updated: February 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
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

Additional relevant MeSH terms:
Lymphoma
Nervous System Neoplasms
Neuroblastoma
Retinoblastoma
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Eye Diseases
Retinal Diseases
Etoposide
Carboplatin
Lenograstim
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014