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

Primary Purpose

Cancer of Skin, Solid Tumors

Status
Terminated
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Immunotherapy treatment for solid tumors
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

  • Hadassah Medical Organization, Jerusalem, Israel

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
January 16, 2006
Last Updated
April 19, 2015
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00278018
Brief Title
Peritumoral Injection of Immature Dendritic Cells to Irradiated Skin Metastases of Solid Tumors
Official Title
Peritumoral Injection of Immature Dendritic Cels to Irradiated Metastases of Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
Because there were no responses
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Skin, Solid Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Immunotherapy treatment for solid tumors
Primary Outcome Measure Information:
Title
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.
Title
Immunological evaluation will be performed two weeks after the last DC injection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Lotem, MD
Organizational Affiliation
Hadassah Medical Organization, pob 12000, Jerusalem, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization, Jerusalem, Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

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

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