A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies
NCT ID: NCT00162500
Last Updated: 2010-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
15 participants
INTERVENTIONAL
Brief Summary
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ImMucin was shown to be able to induce a robust cellular immune response mediated via both CD4+ and CD8+ T lymphocytes and therefore, could potentially be more effective in the majority of the target population.
Purpose:
The purpose of this study is to evaluate the safety and initial efficacy of ImMucin, a novel peptide vaccine in metastatic tumors expressing the MUC-1 Tumor Associated Antigen (TAA).
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Peptide Vaccine (MUC-1)
Eligibility Criteria
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Inclusion Criteria
* Renal Cell Carcinoma (RCC),
* Transitional Cell Carcinoma (TCC),
* Prostate,
* Breast,
* Ovary,
* Non-small cell lung,
* Colon,
* Multiple myeloma and
* Pancreatic.
* Patients must be \>18 years of age, consenting to participation in the study.
* Patients must have at least one site of measurable tumor or measurable tumor marker.
Exclusion Criteria
* Subjects with prior irradiation to a field that includes more than 25% of their lymph nodes and bone marrow likely to be immunosuppressed will be excluded. However, patients who had standard pelvic field radiation such as adjuvant therapy for rectal cancer are not excluded.
* Pregnant and breast feeding women will be excluded. Premenopausal women who are not practicing or willing to practice adequate birth control methods for a period of 3 months after treatment will be excluded.
* Patients with brain metastases.
* Patients with active infection.
* Patients with HIV hepatitis B surface antigen (HBS Ag) and hepatitis C virus (HCV) positive patients.
18 Years
ALL
No
Sponsors
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Vaxil Therapeutics Ltd.
INDUSTRY
Hadassah Medical Organization
OTHER
Principal Investigators
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Shimon Slavin, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Hadassah Medical Organization
Jerusalem, , Israel
Countries
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Other Identifiers
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191203-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id