|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Roswell Park Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| 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: | Treatment |
| Official Title: | High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies |
| Study Start Date: | March 2002 |
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 |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and 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 | |
| Study Chair: | Barbara Jean Bambach, MD | Roswell Park Cancer Institute |
More Information
| Study ID Numbers: | CDR0000269284, RPCI-DS-00-03 |
| Study First Received: | January 27, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00053118 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 lymphoma |
|
Retinal Neoplasms Neuroectodermal Tumors, Primitive Antineoplastic Agents Neoplasms, Nerve Tissue Central Nervous System Neoplasms Retinoblastoma Neuroblastoma Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Lymphoma Etoposide Nervous System Neoplasms Retinal Diseases Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Eye Neoplasms Eye Diseases Nervous System Diseases Carboplatin Pharmacologic Actions Lymphatic Diseases Neuroectodermal Tumors Neoplasms Lymphoproliferative Disorders Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |