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

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.
 
ClinicalTrials.gov Identifier: NCT00162500
Recruitment Status : Withdrawn
First Posted : September 13, 2005
Last Update Posted : November 10, 2010
Sponsor:
Collaborator:
Vaxil Therapeutics Ltd.
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE September 11, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date November 10, 2010
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2007)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
Determine the feasibility and safety of intradermal adminisration of the ImMucin peptide combined with GM-CSF for maximal stimulation of the draining lymphnodes.
Change History Complete list of historical versions of study NCT00162500 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2007)
  • Determine objective anti-tumor response in patients treated with this regimen;
  • Determine immune response in patients treated with this regimen
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
Document development of immune response to the peptide by in-vivo DTH and in-vitro assays and whenever possible, cytotoxic responses mediated by CD8 against HLA identical tumor.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies
Official Title  ICMJE 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Myeloma
  • Tumors
Intervention  ICMJE Biological: Peptide Vaccine (MUC-1)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Estimated Enrollment  ICMJE
 (submitted: September 11, 2005)
15
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00162500
Other Study ID Numbers  ICMJE 191203-HMO-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Vaxil Therapeutics Ltd.
Investigators  ICMJE
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP