Vaccine Therapy With or Without Recombinant Interleukin-12 Followed by Daclizumab in Treating Patients With Metastatic Melanoma
Summary
This randomized phase II trial is studying how well giving vaccine therapy together with or without recombinant interleukin-12 followed by daclizumab works in treating patients with melanoma that has spread to other places in the body. Vaccines made from peptides or antigens may help the body build an effective immune response to kill tumor cells. Recombinant interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating white blood cells to kill melanoma cells. Monoclonal antibodies, such as daclizumab, may decrease the number of regulatory T cells (T cells that suppress the activation of the immmune system) and may lead to a better immune response against melanoma. It is not yet known whether vaccine therapy is more effective with interleukin-12 and daclizumab in treating melanoma.
Timeline
- Start
- 2011-02
- Primary completion
- 2015-01
- Completion
- 2015-02
Outcome
Outcome not reported
Stopped: “Due to lack of clinical efficacy and lack of drug supply, trial was closed early and correlative studies were not pursued further.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MAGE-3.1 | Protein / enzyme biologic | — | Subcutaneous |
| Subject | MART-1 | Peptide | — | Subcutaneous |
| Subject | NA17.A2 | Peptide | — | Subcutaneous |
| Subject | interleukin-12 | Protein / enzyme biologic | — | Subcutaneous |