Peritumoral Injection of Immature Dendritic Cells to Irradiated Skin Metastases of Solid Tumors
Melanoma is the main cause of death in patients with skin cancer. Once it has metastasized, this cancer has been shown to respond to chemotherapy only in rare cases. Immunotherapy represents an approach to treatment based on the immune response to cancer antigens.
The long-term objective of this study is to develop a therapeutic approach for the treatment of cancer in general, and melanoma in particular, based on immunotherapy, using a combination of local tumor irradiation followed by injection of immature dendritic cells (iDC).The treatment will be followed by the injection of interferon alpha, which we expect will induce activation of the iDC.
This trial is based on the hypothesis that local radiation, which causes destruction of the tumor, in combination with injection of the patient's own iDC and the activation of these cells with interferon alpha, will induce an effective immune response against the tumor. In order to test the suggested approach, we propose a 20-patients clinical trial that will evaluate the objective clinical and immunological response to the proposed treatment in patients with malignant melanoma and other solid tumors.
|Cancer of Skin Solid Tumors||Procedure: Immunotherapy treatment for solid tumors||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Peritumoral Injection of Immature Dendritic Cels to Irradiated Metastases of Solid Tumors|
- Complete evaluation of untreated lesions with physical examination and appropriate X-rays and/or scans will be performed four to six weeks after the last DC injection.
- Immunological evaluation will be performed two weeks after the last DC injection.
|Study Start Date:||December 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278018
|Hadassah Medical Organization, Jerusalem, Israel|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Michal Lotem, MD||Hadassah Medical Organization, pob 12000, Jerusalem, Israel|