Chemotherapy and Stem Cell Transplantation in Treating Children with Central Nervous System Cancer - Article
Clinical Trial: Chemotherapy and Stem Cell Transplantation in Treating Children with Central Nervous System Cancer
This study is no longer recruiting patients.
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.
|Condition||Treatment or Intervention||Phase|
|central nervous system cancer |
childhood brain tumor
hematopoietic and lymphoid cancer
| Drug: carboplatin |
Procedure: biological response modifier therapy
Procedure: bone marrow ablation with stem cell support
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
- 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.
Ages Eligible for Study: up to 18 Years, Genders Eligible for Study: Both
- 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
- ECOG 0-2
- 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)
- 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
PRIOR CONCURRENT THERAPY: Biologic therapy
- Not specified
- Not specified
- Not specified
St. Louis Children's Hospital, Saint Louis, Missouri, 63110, United States
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, 77030, United States
Barbara Jean Bambach, MD, Study Chair, Roswell Park Cancer Institute
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
Cache Date: April 9, 2005
- Central Nervous System Lymphoma, Primary (National Cancer Institute)