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A Novel Vaccine for the Treatment of MUC1-Expressing Tumor Malignancies

This study is not yet open for participant recruitment.
Study NCT00162500.   Last updated on January 9, 2007.   Information provided by Hadassah Medical Organization

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Descriptive Information Fields
Brief Title  A Novel Vaccine for the Treatment of MUC1-Expressing Tumor Malignancies
Official Title  A Novel Vaccine for the Treatment of MUC1-Expressing Tumor Malignancies
Brief Summary

Rationale:

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
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary Outcome Measure  Determine the safety and tolerability of vaccination comprising the ImMucin vaccine
combined with Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), in patients
with multiple myeloma and other MUC-1 antigen-expressing metastatic carcinomas
Secondary Outcome Measure  Determine objective anti-tumor response in patients treated with this regimen;
Determine immune response in patients treated with this regimen
Condition  Multiple Myeloma
Tumors
Intervention  Biological: Peptide Vaccine (MUC-1)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Not yet recruiting
Enrollment  15
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • All patients must have a histological or cytological diagnosis of metastatic disease expressing the MUC-1. Patients must have metastatic disease and have failed at least one regimen of standard based chemotherapy for metastatic disease such as:

    • 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:

  • Patients receiving any immunosuppressive treatment that could negate development of an effective immune response to the vaccine.
  • 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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Shimon Slavin, MD     +972-2-6776561     slavin@hadassah.org.il    
Contact: Lior Carmon, PHD, MBA     +972-3-6491190     mkcarmon@inter.net.il    
Location Countries  Israel
Administrative Information Fields
NCT ID  NCT00162500
Organization ID 191203-HMO-CTIL
Secondary IDs ††
Study Sponsor  Hadassah Medical Organization
Collaborators †† Vaxil Therapeutics Ltd.
Investigators 
Principal Investigator:     Shimon Slavin, MD     Hadassah Medical Organization    
Information Provided By Hadassah Medical Organization
Verification Date September 2005
First Received Date  September 11, 2005
Last Updated Date January 9, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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