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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00278018
Recruitment Status : Terminated (Because there were no responses)
First Posted : January 18, 2006
Last Update Posted : April 21, 2015
Information provided by:
Hadassah Medical Organization

January 16, 2006
January 18, 2006
April 21, 2015
December 2005
December 2008   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT00278018 on Archive Site
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Peritumoral Injection of Immature Dendritic Cells to Irradiated Skin Metastases of Solid Tumors
Peritumoral Injection of Immature Dendritic Cels to Irradiated 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.

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Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cancer of Skin
  • Solid Tumors
Procedure: Immunotherapy treatment for solid tumors
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2008
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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:

    • for melanoma - DTIC -containing protocol ,unless unwilling. Previous treatment with IL-2 is not an excluding factor.
    • for breast cancer - adriamycin and cyclophosphamide, taxanes, and vinorelbine-containing protocols
    • for lung, renal and GIT cancers- one previous chemotherapy line
  2. Serum creatinine of 2.0 mg/dl or less.
  3. Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
  4. WBC 3000/mm3 or greater.
  5. Platelet count 90,000 mm3 or greater.
  6. Serum AST/ALT less then two times normal.
  7. ECOG performance status of 0, 1 or 2.
  8. Patients of both genders must be willing to practice effective birth control during this trial.
  9. Patient agreed to participate in the study and has signed a written informed consent.

Exclusion Criteria:

Patients will be excluded:

  1. who are undergoing or have undergone in the past 3 weeks any other form of therapy except from surgery for their cancer.
  2. have active systemic infections, coagulation disorders, autoimmune disease or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease.
  3. who require steroid therapy.
  4. who are pregnant (because of possible side effects on the fetus).
  5. who are known to be positive for hepatitis B and C or HIV antibody (because of possible immune effects of these conditions).
  6. who have any form of primary or secondary immunodeficiency. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
  7. who are allergic to eggs.

i. who have an active major medical illnesses such as cardiac ischemia

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
immatureDC- HMO-CTIL
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Hadassah Medical Organization
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Principal Investigator: Michal Lotem, MD Hadassah Medical Organization, pob 12000, Jerusalem, Israel
Hadassah Medical Organization
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP