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| ID | Type | Description | Link |
|---|---|---|---|
| CHLA-NYU-0007H | |||
| NCI-G01-2019 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy, surgery, radiation therapy, and bone marrow or peripheral stem cell transplantation in treating patients who have primary CNS germ cell tumors.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to risk status (low vs intermediate or high).
Regimen A (Low-risk patients)
Regimen B (Intermediate and high-risk patients)
Quality of life is assessed before bone marrow or PBSCS and then every 2 years thereafter.
Patients are followed at day 42, at 3 months, then every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 80 patients (40 per stratum) will be accrued for this study within 4 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | |||
| carboplatin | Drug | |||
| cyclophosphamide | Drug | |||
| etoposide | Drug | |||
| thiotepa | Drug | |||
| autologous bone marrow transplantation | Procedure | |||
| bone marrow ablation with stem cell support | Procedure | |||
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed primary CNS germ cell tumor OR
Serum or cerebrospinal fluid (CSF) elevation of alpha-fetoprotein (AFP) or beta-human chorionic gonadotropin (beta-HCG) greater than 50 ng/mL
Low-risk disease:
Intermediate-risk disease:
High-risk disease:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan L. Finlay, MB, ChB | Children's Hospital Los Angeles | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027-0700 | United States | ||
| Children's Hospital of the King's Daughters |
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| conventional surgery |
| Procedure |
| peripheral blood stem cell transplantation | Procedure |
| radiation therapy | Radiation |
| Norfolk |
| Virginia |
| 23507 |
| United States |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6001 | Australia |
| Tom Baker Cancer Centre - Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016190 | Carboplatin |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D013852 | Thiotepa |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| 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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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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