Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Study of Temozolomide and Radiation in Newly Diagnosed GBM Patients After Resection and Insertion of Gliadel® Wafers
Verified date | June 2018 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide during and
after radiation therapy may kill any tumor cells that remain after surgery and placement of
Gliadel wafers.
PURPOSE: This phase II trial is studying how well giving temozolomide during and after
radiation therapy works in treating patients who have undergone previous surgery and
placement of Gliadel wafers for newly diagnosed glioblastoma multiforme.
Status | Terminated |
Enrollment | 15 |
Est. completion date | December 11, 2007 |
Est. primary completion date | December 11, 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme) - Underwent gross total resection within the past 6 weeks - Postoperative contrast-enhancing tumor extends = 1 cm from the margin of the surgical cavity - 6-8 polifeprosan 20 with carmustine implants (GliadelĀ® wafers) were placed in the surgical resection cavity at time of surgery PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count = 1,500/mm^3 - Platelet count = 100,000/mm^3 Hepatic - Bilirubin = 1.5 mg/dL - Transaminases = 4 times upper limit of normal Renal - Creatinine = 1.7 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known hypersensitivity reaction to temozolomide - No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy for the brain tumor - No prior biologic agents (e.g., immunotoxins, immunoconjugates, antisense agents, peptide-receptor agonists, interferons, interleukins, tumor-infiltrating lymphocyte therapy, lymphokine-activated killer cell therapy, or gene therapy) for the brain tumor Chemotherapy - See Disease Characteristics - No other prior chemotherapy for the brain tumor Endocrine therapy - No prior hormonal therapy for the brain tumor - Prior glucocorticoid therapy allowed Radiotherapy - No prior radiotherapy for the brain tumor Surgery - See Disease Characteristics |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | National Cancer Institute (NCI) |
United States,
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---|---|---|---|---|
Primary | Death |
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