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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-DS-00-03 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | IV | ||
| carboplatin | Drug | IV | ||
| etoposide | Drug | IV | ||
| bone marrow ablation with stem cell support | Procedure | IV | ||
| peripheral blood stem cell transplantation | Procedure | IV |
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
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Jean Bambach, MD | Roswell Park Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States | ||
| Roswell Park Cancer Institute |
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| Buffalo |
| New York |
| 14263-0001 |
| United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D008223 | Lymphoma |
| D009447 | Neuroblastoma |
| D012175 | Retinoblastoma |
| D016545 | Choroid Plexus Neoplasms |
| D001254 | Astrocytoma |
| C531673 | Familial ependymoma |
| D008527 | Medulloblastoma |
| D020339 | Optic Nerve Glioma |
| D018335 | Rhabdoid Tumor |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D019572 | Retinal Neoplasms |
| D005134 | Eye Neoplasms |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D002551 | Cerebral Ventricle Neoplasms |
| D001932 | Brain Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D005910 | Glioma |
| D019574 | Optic Nerve Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D010524 | Peripheral Nervous System Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009901 | Optic Nerve Diseases |
| D018193 | Neoplasms, Complex and Mixed |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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