drugset / Trial / NCT00436930

Vaccine Therapy and GM-CSF in Treating Patients With Recurrent or Metastatic Melanoma

NCT00436930

Phase 2 Completed 200 enrolled Hoag Memorial Hospital Presbyterian
RandomizedTreatment

Summary

RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment for melanoma. PURPOSE: This randomized phase II trial is studying two different vaccine therapy regimens to compare how well they work when given together with GM-CSF in treating patients with recurrent or metastatic melanoma.

Timeline

Start
2006-12
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject autologous tumor cell vaccine Vaccine Subcutaneous
Subject therapeutic autologous dendritic cells Vaccine Subcutaneous
Background sargramostim Protein / enzyme biologic 500 ug Subcutaneous

Indications