Status:
TERMINATED
Peritumoral Injection of Immature Dendritic Cells to Irradiated Skin Metastases of Solid Tumors
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Cancer of Skin
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 approa...
Eligibility Criteria
Inclusion
- 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
- Serum creatinine of 2.0 mg/dl or less.
- 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.
- WBC 3000/mm3 or greater.
- Platelet count 90,000 mm3 or greater.
- Serum AST/ALT less then two times normal.
- ECOG performance status of 0, 1 or 2.
- Patients of both genders must be willing to practice effective birth control during this trial.
- Patient agreed to participate in the study and has signed a written informed consent.
Exclusion
- Patients will be excluded:
- who are undergoing or have undergone in the past 3 weeks any other form of therapy except from surgery for their cancer.
- have active systemic infections, coagulation disorders, autoimmune disease or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease.
- who require steroid therapy.
- who are pregnant (because of possible side effects on the fetus).
- who are known to be positive for hepatitis B and C or HIV antibody (because of possible immune effects of these conditions).
- 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.)
- who are allergic to eggs.
- i. who have an active major medical illnesses such as cardiac ischemia
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00278018
Start Date
December 1 2005
End Date
December 1 2008
Last Update
April 21 2015
Active Locations (1)
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1
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel, 91120