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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162500
First Posted: September 13, 2005
Last Update Posted: November 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vaxil Therapeutics Ltd.
Information provided by:
Hadassah Medical Organization
  Purpose

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).


Condition Intervention Phase
Multiple Myeloma Tumors Biological: Peptide Vaccine (MUC-1) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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 Measures:
  • Determine objective anti-tumor response in patients treated with this regimen;
  • Determine immune response in patients treated with this regimen

Estimated Enrollment: 15
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162500


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Vaxil Therapeutics Ltd.
Investigators
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00162500     History of Changes
Other Study ID Numbers: 191203-HMO-CTIL
First Submitted: September 11, 2005
First Posted: September 13, 2005
Last Update Posted: November 10, 2010
Last Verified: September 2005

Keywords provided by Hadassah Medical Organization:
Metastatic solid tumors

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs


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