A Phase II Study Of Matured Dendritic Cells Pulsed Ex Vivo With 3 Melanoma Cell Line Lysates (IDD-3) in Patients With In-Transit or Metastatic Melanoma
- Determine the clinical activity of vaccine therapy comprising autologous dendritic
cells pulsed with allogeneic melanoma tumor cell lysates (IDD-3), as measured by tumor
control, in patients with unresected stage IIIB or IIIC or stage IV melanoma.
- Determine the immunologic activity of this vaccine, as measured by T-cell and antibody
responses to lysate or to melanoma antigens or peptides, in these patients.
- Determine the safety of this vaccine, as measured by the incidence and severity of
adverse events, in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients undergo apheresis to collect peripheral blood mononuclear cells (PBMCs). The PBMCs
are cultured with sargramostim (GM-CSF) and interleukin-13 for the production of dendritic
cells. The dendritic cells are then pulsed with lysates from 3 allogeneic melanoma tumor
cell lines (IDD-3) to produce the vaccine.
Patients receive vaccine therapy comprising IDD-3 administered as 1 subcutaneous and 5
intradermal injections at each of the 2 uninvolved lymph node-bearing regions once in weeks
0, 2, 4, 6, 8, 10, 16, and 22 in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed at 2, 10, 18, and 26 weeks.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12
Masking: Open Label, Primary Purpose: Treatment
Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks
Antoni Ribas, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|