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Peritumoral Injection of Immature Dendritic Cells to Irradiated Skin Metastases of Solid Tumors

NCT00278018 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-04-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Immunotherapy treatment for solid tumors

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Michal Lotem, MD · Hadassah Medical Organization, pob 12000, Jerusalem, Israel

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00278018 on ClinicalTrials.gov