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| ID | Type | Description | Link |
|---|---|---|---|
| POHA-0601 |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Tamoxifen may make tumor cells more sensitive to radiation therapy and chemotherapy. Giving radiation therapy together with temozolomide, tamoxifen, and carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving radiation therapy together with temozolomide, tamoxifen, and carboplatin works in treating patients with malignant gliomas.
OBJECTIVES:
OUTLINE: This is an open-label, pilot study.
After completion of study treatment, patients are followed periodically for 5 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| tamoxifen citrate | Drug | |||
| temozolomide | Drug | |||
| adjuvant therapy | Procedure | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | ||
| Overall survival | ||
| Toxicity | ||
| Tumor response |
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DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme and/or anaplastic astrocytoma
Has undergone surgery within the past 6 weeks
No recurrent glioblastoma multiforme
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Edward F. McClay, MD | San Diego Pacific Oncology & Hematology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas | Recruiting | Encinitas | California | 92024 | United States |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D001254 | Astrocytoma |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D013629 | Tamoxifen |
| D000077204 | Temozolomide |
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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