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Sponsored by: |
Hadassah Medical Organization |
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Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00278018 |
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.
Condition | Intervention | Phase |
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Cancer of Skin Solid Tumors |
Procedure: Immunotherapy treatment for solid tumors |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Peritumoral Injection of Immature Dendritic Cels to Irradiated Metastases of Solid Tumors |
Estimated Enrollment: | 20 |
Study Start Date: | December 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Any patient above age 18, with measurable metastatic melanoma or other solid tumor, with at least one tumor deposit that is easily accessible to peri-tumoral DC injection. The preferred location is subcutaneous or intradermal. Patients with additional metastatic sites will not be excluded. Patients should have an expected survival of greater than three months.
Patient must have received accepted standard treatment of his or her cancer:
Exclusion Criteria:
Patients will be excluded:
i. who have an active major medical illnesses such as cardiac ischemia
Contact: Michal Lotem, MD | 0508573528 | mlotem@hadassah.org.il |
Israel | |
Hadassah Medical Organization, Jerusalem, Israel | Recruiting |
Jerusalem, Israel, 91120 | |
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il | |
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il | |
Sub-Investigator: Shoshana Frankenburg, PhD | |
Principal Investigator: Michal Lotem, MD |
Principal Investigator: | Michal Lotem, MD | Hadassah Medical Organization, pob 12000, Jerusalem, Israel |
Study ID Numbers: | immatureDC- HMO-CTIL |
Study First Received: | January 16, 2006 |
Last Updated: | April 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00278018 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Skin Diseases Neoplasm Metastasis Skin Neoplasms |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |