Status: Closed
Activation Date: 2002JAN10
Closing Date: 2002DEC17
Phase: II
Description: A Phase II Study of SarNU (NSC 364432) in Patients With Malignant Glioma
Eligibility: Patients with recurrent histologically proven malignant glioma (anaplastic astrocytoma or glioblastoma multiforme). Patients with anaplastic astrocytoma may have had up to ONE prior chemotherapy regimen in the adjuvant setting, but NO chemotherapy for recurrence. Patients with glioblastoma multiforme must be chemotherapy-naive. Bidimensionally measurable enhancing lesions on CT or MRI.
Objective: To determine the efficacy of SarCNU given orally on days 1, 5 and 9 every 6 weeks in patients with recurrent malignant glioma. To determine time to progression, survival and qualitative and quantitative toxicity of SarCNU in this schedule in this patient population. Laboratory correlative studies will also be done.
Lay Description: The purpose of this study is to find out what effects the experimental drug SarCNU has on patients with malignant glioma. In addition, this study will evaluate the side effects of SarCNU. This research is being done because SarCNU has not been tested in brain tumours and it comes from a family of drugs which are known to be effective in some patients.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I142 | 10 | 2 | 4 | 6 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I142 | 10 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I142 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |