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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00034554 | Study of gp75 Vaccine in Patients With Stage III and IV Melanoma | PHASE1 | COMPLETED | 31 | — | — | Mar 1, 2002 | Sep 1, 2004 | Apr 9, 2010 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 0.1mg |
| 2 | EXPERIMENTAL | 0.5mg |
| 3 | EXPERIMENTAL | 2.0mg |
| 4 | EXPERIMENTAL | 4.0mg |
| 5 | EXPERIMENTAL | 8.0mg |
| Name | Type | Description |
|---|---|---|
| gp75 DNA vaccine | BIOLOGICAL | 6 patients will be enrolled in each of the 5 vaccination groups. Patients in vaccination groups 1-3 will receive a total of 5(1 mL) vaccinations. Patients assigned to vaccination group 4 will receive a total of 5 (2.0 mL) vaccinations administered as 2 1 mL injections. Patients assigned to vaccination group 5 will receive a total of 5 (4.0 mL or 8.0 mg)vaccinations administered as 4 1 mL injections per vaccination treatment Patients will receive gp75 DNA vaccinations every 3 weeks for 5 vaccinations. Injection sites will be given intramuscularly and rotated for each dose using all 4 limbs with the exception of a site that had the removal of lymph nodes. Progression to next higher dose level will be based on the 5\* patient safely completing the 2nd vaccination at the lower dose level. |
Inclusion Criteria: 1. The patient has a diagnosis of American Joint Commission on Cancer (AJCC) stage 111 or IV malignant melanoma. A patient who is free of disease after surgical resection of stage 111 or IV disease, but at high risk (defined as a primary tumor \>4 rnm, satellite or in-transit le...