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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00033228 | Vaccine Therapy in Treating Patients With Stage IV Melanoma | PHASE1 | COMPLETED | 19 | — | — | Jan 1, 2002 | Apr 1, 2003 | May 12, 2011 | 5 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | The first cohort of 6 patients received 500 ug of Synchrovax SEM plasmid DNA vaccine. All patients were to be monitored for dose limiting toxicities DLTs) for a minimum of 2 weeks after their second infusion of vaccine on Day 15 before allowing patients to enroll at the next dose group. The decision to progress to the next dose group was to be based on occurrence of DLTs observed in 1 or fewer (\<33%) patients of a 6 patient cohort. |
| Cohort 2 | EXPERIMENTAL | The second cohort of 6 patients received 1000 ug of Synchrovax SEM plasmid DNA vaccine. All patients were to be monitored for dose limiting toxicities DLTs) for a minimum of 2 weeks after their second infusion of vaccine on Day 15 before allowing patients to enroll at the next dose group. The decision to progress to the next dose group was to be based on occurrence of DLTs observed in 1 or fewer (\<33%) patients of a 6 patient cohort. |
| Cohort 3 | EXPERIMENTAL | The third cohort of 6 patients received 1500 ug of Synchrovax SEM plasmid DNA vaccine. The maximum tolerated dose (MTD) was to be determined by the observation of DLT at each dose group. |
| Name | Type | Description |
|---|---|---|
| MKC1106-MT | BIOLOGICAL | Cancer Vaccine, Immunotherapy, 500 ug |
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV melanoma * Must have tumor tissue available for determining antigen expression * At least 10% of tumor cells must stain positive for Melan-A/Mart-1 by immunohistochemistry * HLA-A2 positive * No brain metastases unless completely resec...