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The Role of Peptide-loaded Dendritic Cells to Augment the Therapeutic Effect of Interleukin-2

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00279058
First Posted: January 19, 2006
Last Update Posted: April 21, 2015
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.
Information provided by:
Hadassah Medical Organization
  Purpose

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 principal objective of the study is to identify whether a dendritic cell-based vaccine can increase the moderate therapeutic effect of bolus high dose IL-2 in patients with metastatic melanoma. For this purpose,patients with metastatic melanoma who have a certain blood type (HLA-A201+) will be treated systemically with high dose IL-2. In one group of patients, the IL-2 will be preceded by three doses of autologous dendritic cell pulsed with melanoma antigens appropriate for their blood type. Two cycles of three DC vaccines will be administered every 14 days by intra-lymph node injections, followed by high dose IL-2 treatment. Responding patients will receive additional DC vaccines at 1 month and 2 months intervals.

In a second group, patients will receive the standard high dose IL-2 protocol within a comparable period of time.

Each group will include 12 patients.

A complete evaluation of evaluable lesions will be performed prior to accrual, after initial 3 DC vaccines, six weeks after first IL-2 treatment, after a total of 6 DC vaccines and 6 weeks after second cycle of IL-2 treatment.


Condition Intervention Phase
Metastatic Melanoma Procedure: Immunotherapy treatment for melanoma Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Autologous Dendritic Cells Pulsed by Melanoma Associated Peptides to Augment the Therapeutic Effect of Interleukin-2

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 24
Study Start Date: December 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Any patient age 18 to 65, with measurable metastatic melanoma who has an expected survival of greater than three months. All patients will be HLA-A2 positive

    • Patient must have received accepted standard treatmnet for melanoma - DTIC -containing protocol ,unless unwilling.
    • Patients who failed previous treatment with IL-2 will be included on a compassionate basis in the IL-2 plus vaccination scheme without being included in the analysis.
  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,
  10. The patient must be eligible to receive IL-2.

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 BsAG, HCV, 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 as evidenced by a stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease (to be eligible to receive IL-2 ) j. Have an abnormal thyroid function (to be eligible to receive IL-2).

  Contacts and Locations
Information from the National Library of Medicine

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): NCT00279058


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91 120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Michal Lotem, MD Hadassah Medical Organization, pob 12000, Jerusalem, Israel
  More Information

ClinicalTrials.gov Identifier: NCT00279058     History of Changes
Other Study ID Numbers: pepDCIL2- HMO-CTIL
First Submitted: January 17, 2006
First Posted: January 19, 2006
Last Update Posted: April 21, 2015
Last Verified: April 2007

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs