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

Primary Purpose

Brain and Central Nervous System Tumors, Lymphoma, Neuroblastoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
filgrastim
carboplatin
etoposide
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Louis Children's Hospital
  • Roswell Park Cancer Institute
  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 27, 2003
Last Updated
February 25, 2011
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00053118
Brief Title
Chemotherapy and Stem Cell Transplantation in Treating Children With Central Nervous System Cancer
Official Title
High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Lymphoma, Neuroblastoma, Retinoblastoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
IV
Intervention Type
Procedure
Intervention Name(s)
bone marrow ablation with stem cell support
Intervention Description
IV
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Description
IV

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Jean Bambach, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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