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Peritumoral Injection of Immature Dendritic Cels to Irradiated Metastases of Solid Tumors

Phase 1/Phase 2
18 Years
Open (Enrolling)
Cancer of Skin, Solid Tumors

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Trial Information

Peritumoral Injection of Immature Dendritic Cels to Irradiated Metastases of Solid Tumors

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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:

immatureDC- HMO-CTIL



Start Date:

December 2005

Completion Date:

Related Keywords:

  • Cancer of Skin
  • Solid Tumors
  • Skin Neoplasms
  • Neoplasm Metastasis
  • Neoplasms