| Neuro Oncology
Trials |
| TITLE |
E 1F02: A Phase II Study of Systemic High-Dose Methotrexate for the Treatment of Glioblastoma Multiforme
(GBM) in Newly Diagnosed Patients with Measurable Disease |
| DESCRIPTION |
This study will determine the response of patients with newly diagnosed glioblastoma multiforme to high dose methotrexate
(HDMTX). Patients will receive systemic HDMTX every 14 days (+/- 2 days) for up to 6 cycles. |
| ELIGIBILITY
|
- Age > 18 years.
- Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma
multiforme).
- ECOG performance status 0 – 2
- Patients must not have received prior radiation therapy, chemotherapy, hormonal therapy, immunotherapy or therapy with biologic agents
- Patients much have normal bone marrow, liver and kidney function.
- Patients must not be receiving concurrent chemotherapy or investigational agents for GBM or any other disease.
|
| CONTACT |
Kim Rutherford RN 216-844-8988 |
|
| TITLE |
CWRU 6Y02: 11C Topotecan PET Imaging |
| DESCRIPTION |
This study is being done to label topotecan with 11C in order to determine whether or not 11C topotecan imaging has potential to be an early predictor of response to topotecan therapy. Patients will receive 11C Topotecan intravenously over 10 minutes. Immediately after, a PET scan will be performed in Nuclear Medicine. CT imaging and FDG Pet imaging will also be performed. |
| ELIGIBILITY |
- Patients must have histologically documented ovarian carcinoma, small cell lung cancer, or other cancer with brain metastases that make the subject a candidate for topotecan therapy based on their primary oncologist’s clinical decision.
- Patients must have a life expectancy of greater than 12 weeks.
- Patients must have measurable disease on CT and/or
MRI.
- Patients must have normal kidney and bone marrow function.
|
| CONTACT |
Beverly
McGloin 216-844-2528 |
|
| TITLE |
RTOG 98-13: A Phase I/III Randomized Study of Radiation Therapy and Temozolomide Versus Radiation Therapy and BCNU for Anaplastic Astrocytoma |
| DESCRIPTION |
This study will compare overall survival of patients randomized to one
of four arms of this study. Patients randomized to arm 1 will receive radiation therapy 5
days a week for 6 weeks and temozolomide on days 1-5 of the first week of radiotherapy.
Temozolomide will be repeated every 28 days for a total of 12 cycles. Patients
randomized to arm 2 will receive radiation therapy 5 days a week for 6 weeks plus
BCNU on days 1, 2, and 3 of the first week of radiotherapy and on days 56, 57, and 58,
then every eight weeks for 4 cycles for a total of six cycles. The proposed arm 3 has been
dropped. Patients randomized to arm 4 will receive radiation therapy 5 days a week for 6
weeks plus BCNU on day 1 of radiotherapy and temozolomide on days 1-5 of the first
week or radiotherapy. Chemotherapy will be repeated every 6 weeks for a total of 6
cycles. Patients randomized to arm 5 will receive radiation therapy 5 days a week for 6
weeks, plus BCNU on day 5 of radiotherapy and temozolomide on days 1-5 of the first
week of radiotherapy. Chemotherapy will be repeated every 8 weeks for a total of 6
cycles. |
| ELIGIBILITY |
- Patients must have histologically confirmed unifocal anaplastic astrocytoma or mixed
oligodendroglia/astrocytic tumors where the oligodendroglial component is
less than 25%.
- Patients must have adequate bone marrow, renal and hepatic function.
- Patients must not have received prior radiation to the brain or head/neck.
- Patients must not have received prior chemotherapy.
|
| CONTACT |
Beverly
McGloin 216-844-2528 |
|
| TITLE |
CWRU 1302:
Phase II Trial of Conventional Radiotherapy with Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients with Glioblastoma
Multiforme |
| DESCRIPTION |
This study will determine the feasibility and efficacy of the addition of stereotactic radiosurgery focused at areas of high risk determined by functional imaging combined with conventional radiotherapy for patients with glioblastomas. Patients will receive stereotactic radiosurgery to a high risk volume determine by MR-spectroscopy followed by conventional radiotherapy to begin within 2 weeks after radiosurgery. |
| ELIGIBILITY |
- Patients must have histopathologically confirmed WHO grade IV malignant glioma (glioblastoma) diagnosed by surgical biopsy or resection.
- Patients must have recovered from the effects of surgery or any post-operative complication before entry into the study.
- Study treatment must begin within five weeks of surgery.
- A diagnostic contrast enhanced MRI scan with MR spectroscopy must be performed post-operatively prior to initiation of radiotherapy, including radiosurgery and the area of high risk defined on post-operative MR spectroscopy must meet the following Radiosurgery Criteria: Maximum diameter greater than or equal to 40 mm, located > 5mm from the optic nerve or chiasm, and does not involve the brainstem.
- Patients may not have had previous in-field radiotherapy to the head and neck area.
|
| CONTACT |
Beverly
McGloin 216-844-2528 |
| |
