Chemotherapy and Stem Cell Transplantation in Treating Children With Central Nervous System Cancer - Full Text View

Sponsor:	Roswell Park Cancer Institute
Information provided by:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00053118

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 I

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:

Genetics Home Reference related topics: neuroblastoma retinoblastoma

MedlinePlus related topics: Cancer Lymphoma Neuroblastoma

Drug Information available for: Etoposide Carboplatin Etoposide phosphate Filgrastim Lenograstim Granulocyte colony-stimulating factor

U.S. FDA Resources

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:

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

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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 February 09, 2012