Vaccine Therapy in Treating Patients With High-Risk Stage III or Completely Resected Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00019890|
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : June 20, 2013
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have high-risk stage III or completely resected metastatic melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Melanoma Stage III Melanoma Recurrent Melanoma||Drug: dendritic cell-gp100-MART-1 antigen vaccine Drug: sargramostim||Phase 2|
I. Determine the immunologic activity of CD34+ derived and peripheral monocyte derived dendritic cells pulsed with MART-1 and gp100 melanoma antigens in patients with high risk stage III or completely resected metastatic melanoma.
PROTOCOL OUTLINE: This is a randomized study. Patients receive dendritic cells derived either from peripheral monocytes or CD34+ cells.
Dendritic cells are pulsed with MART-1 and gp100 immunodominant HLA-A201 peptides prior to infusion, and are administered intralymphatically in the lower extremities for the first 2 courses. Beginning with courses 3 and 4, dendritic cells are administered subcutaneously in the anterior thigh. Dendritic cells are not administered to any extremity that has undergone lymph node dissection.
Patients are randomized to the following treatment arms:
Arm I: Patients undergo leukapheresis to obtain peripheral monocytes. Patients receive dendritic cells derived from peripheral mononuclear cells pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses.
Arm II: Patients receive 5 daily subcutaneous injections of filgrastim (G-CSF) followed by leukapheresis on days 5 and/or 6. Patients receive dendritic cells derived from CD34+ cells pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses.
Patients are followed at 4 to 6 weeks.
A maximum of 28 patients (14 per treatment arm) will be accrued for this study within 7 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Randomized Study of CD34+ Derived or Peripheral Monocyte Derived Dendritic Cells Pulsed With MART-1 and gp100 Melanoma Antigens in Patients With High Risk Stage III or Completely Resected Metastatic Melanoma|
|Actual Study Completion Date :||March 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019890
|Study Chair:||Patrick Hwu||National Cancer Institute (NCI)|