Temozolomide in Patients With Newly Diagnosed Anaplastic Oligodendroglioma and Mixed Oligoastrocytoma
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/2/2017 |
| Start Date: | May 2005 |
| End Date: | March 2011 |
Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Anaplastic Oligodendroglioma and Mixed Oligoastrocytoma
Rationale:
Standard therapy for anaplastic oligodendrogliomas and mixed oligoastrocytomas includes
radiation and chemotherapy. However, due to the potential long-term central nervous system
toxicity from radiation, researchers speculate that it may be better to reserve radiation
therapy for progressive disease. In addition, some patients with anaplastic oligodendroglioma
and mixed oligoastrocytoma have unusually chemosensitive tumors. Previous research indicates
that brain tumor patients with a deletion of the 1p chromosome have a higher response to the
chemotherapy drug temozolomide.
Standard therapy for anaplastic oligodendrogliomas and mixed oligoastrocytomas includes
radiation and chemotherapy. However, due to the potential long-term central nervous system
toxicity from radiation, researchers speculate that it may be better to reserve radiation
therapy for progressive disease. In addition, some patients with anaplastic oligodendroglioma
and mixed oligoastrocytoma have unusually chemosensitive tumors. Previous research indicates
that brain tumor patients with a deletion of the 1p chromosome have a higher response to the
chemotherapy drug temozolomide.
Temozolomide has demonstrated clinical antitumor efficacy against malignant gliomas at both
relapse and initial diagnosis. This drug appears to have less adverse effects compared to
other drugs used against brain tumors. Therefore, temozolomide is often better tolerated in
brain tumor patients compared to other brain tumor drugs. The current study builds on
previous research to test the efficacy of chemotherapy alone in patients with anaplastic
oligodendroglioma and mixed oligoastrocytoma.
Purpose:
This study will evaluate response rate, or how the disease size changes in patients, and
survival without disease growth, in patients with anaplastic oligodendroglioma and mixed
oligoastrocytoma treated with temozolomide. Quality of life will also be assessed in this
patient population treated with the study regimen.
Treatment:
Study participants will be treated with the drug temozolomide. This drug will be administered
in oral pills. Temozolomide will be taken for seven consecutive days followed by seven days
without the drug. This treatment schedule of seven days on temozolomide followed by seven
days off will continue throughout the study. Several tests and exams will be given to closely
monitor patients. MRI scans will be performed every 8 weeks to measure disease response.
Temozolomide as a study drug will be given to study participants for a total of 8 week four
cycles. However, treatments will be discontinued due to disease growth or unacceptable
adverse events.
relapse and initial diagnosis. This drug appears to have less adverse effects compared to
other drugs used against brain tumors. Therefore, temozolomide is often better tolerated in
brain tumor patients compared to other brain tumor drugs. The current study builds on
previous research to test the efficacy of chemotherapy alone in patients with anaplastic
oligodendroglioma and mixed oligoastrocytoma.
Purpose:
This study will evaluate response rate, or how the disease size changes in patients, and
survival without disease growth, in patients with anaplastic oligodendroglioma and mixed
oligoastrocytoma treated with temozolomide. Quality of life will also be assessed in this
patient population treated with the study regimen.
Treatment:
Study participants will be treated with the drug temozolomide. This drug will be administered
in oral pills. Temozolomide will be taken for seven consecutive days followed by seven days
without the drug. This treatment schedule of seven days on temozolomide followed by seven
days off will continue throughout the study. Several tests and exams will be given to closely
monitor patients. MRI scans will be performed every 8 weeks to measure disease response.
Temozolomide as a study drug will be given to study participants for a total of 8 week four
cycles. However, treatments will be discontinued due to disease growth or unacceptable
adverse events.
Inclusion Criteria:
- anaplastic oligodendroglioma or mixed oligoastrocytoma
- age > 18
- Karnofsky status > 70%
- adequate bone marrow, liver and renal function
Exclusion Criteria:
- prior chemotherapy or cranial irradiation
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