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The Role of Autologous Dendritic Cells Pulsed by Melanoma Associated Peptides to Augment the Therapeutic Effect of Interleukin-2

Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
Metastatic Melanoma

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Trial Information

The Role of Autologous Dendritic Cells Pulsed by Melanoma Associated Peptides to Augment the Therapeutic Effect of Interleukin-2

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).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Principal Investigator

Michal Lotem, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization, pob 12000, Jerusalem, Israel


Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

December 2005

Completion Date:

Related Keywords:

  • Metastatic Melanoma
  • Melanoma