Temozolomide During and After Radiation Therapy in Treating Patients Who Have Undergone Previous Surgery and Placement of Gliadel Wafers for Newly Diagnosed Glioblastoma Multiforme
| Status: | Terminated |
|---|---|
| Conditions: | Brain Cancer, Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 6/29/2018 |
| Start Date: | February 15, 2005 |
| End Date: | December 11, 2007 |
Phase II Study of Temozolomide and Radiation in Newly Diagnosed GBM Patients After Resection and Insertion of Gliadel® Wafers
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.
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.
OBJECTIVES:
- Determine the efficacy of adjuvant temozolomide when administered during and after
external beam radiotherapy, in terms of survival, in patients with newly diagnosed
glioblastoma multiforme who have undergone prior total surgical resection and placement
of polifeprosan 20 with carmustine implant (Gliadel® wafers).
OUTLINE: This is an open-label study.
Patients undergo external beam radiotherapy 5 days a week for 6 weeks and concurrently
receive oral temozolomide once daily for 6 weeks. No more than 28 days later, patients
receive additional oral temozolomide once daily on days 1-5. Treatment with temozolomide
repeats every 28 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months for survival.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 18 months.
- Determine the efficacy of adjuvant temozolomide when administered during and after
external beam radiotherapy, in terms of survival, in patients with newly diagnosed
glioblastoma multiforme who have undergone prior total surgical resection and placement
of polifeprosan 20 with carmustine implant (Gliadel® wafers).
OUTLINE: This is an open-label study.
Patients undergo external beam radiotherapy 5 days a week for 6 weeks and concurrently
receive oral temozolomide once daily for 6 weeks. No more than 28 days later, patients
receive additional oral temozolomide once daily on days 1-5. Treatment with temozolomide
repeats every 28 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months for survival.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 18 months.
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 (Gliadel® 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
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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