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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00590954 | Clinical and Molecular-Metabolic Phase II Trial of Perifosine for Recurrent/Progressive Malignant Gliomas | PHASE2 | COMPLETED | 32 | — | — | May 1, 2006 | Nov 11, 2019 | Oct 19, 2020 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death. |
| Name | Type | Description |
|---|---|---|
| Perifosine | DRUG | Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home. In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4. |
Inclusion Criteria: * Patients must have shown unequivocal evidence for tumor progression by MRI or CT scan. * Patients must be on a stable or decreasing dose of corticosteroids for a minimum of 5 days before the baseline MRI and PET scans. * Patients must have failed prior radiation therapy. * Pat...