Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00589875 | Phase 2a Study of CAN-2409 With Standard Radiation Therapy for Malignant Glioma | PHASE2 | COMPLETED | 52 | — | — | Mar 1, 2007 | Aug 1, 2016 | Apr 3, 2024 | 4 | United States |
| Arm | Type | Description |
|---|---|---|
| Single arm | EXPERIMENTAL | This study is an extension of evaluation of the surgical resection arm, Arm B, from a phase Ib study in which dose escalation on arm B was completed. |
| Name | Type | Description |
|---|---|---|
| CAN-2409 | BIOLOGICAL | Single dose of 3x10e11 vector particles of CAN-2409 delivered to the tumor bed after resection on day 0. |
| Valacyclovir | DRUG | Single course of valacyclovir at dose of 2 grams orally three times per day for 14 days starting on day 1-3 |
| Temozolomide | DRUG | Concomitant TMZ will be administered orally once a day at a dose of 75 mg/m2 starting the next day after completing prodrug and continued for 6 weeks. Adjuvant TMZ will be administered days 1 to 5 of a 28-day cycle for 6 cycles with 150 mg/m2 administered for cycle 1, and 150 to 200 mg/m2 administered for cycles 2 to 6. Adjuvant treatment will start 1 month following completing RT. |
| Radiation therapy | RADIATION | Radiation will be administered to up-front patients as per standard of care for the patient. It will start 3-7 days after CAN-2409 injection, preferably closer to 3 days. It will consist of standard external field radiation, limited to the area of tumor and brain adjacent to tumor, fractionated at doses of 200cGy per day for approximately 6 weeks to a total of 5500-6000 cGy. |
Inclusion Criteria: * Patients must have presumed resectable or partially resectable malignant glioma based on clinical and radiologic evaluation (pathologic confirmation of malignant glioma must be made at the time of surgery if not previously determined). Patients who have previously received CAN...