A Study to Assess the Safety and Efficacy of MUC1 Peptide Vaccine and hGM-CSF in Patients With MUC1-positive 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. Identifier: NCT01232712
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : August 9, 2013
Information provided by (Responsible Party):
Vaxil Therapeutics Ltd.

Brief Summary:
The scientific approach behind this study is to develop novel anti-cancer therapeutic vaccine to induce a robust cellular immune response mediated via both CD4+ and CD8+ T lymphocytes populations and can be be applicable to the majority of the target population.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: ImMucin, hGM-CSF Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Study Start Date : September 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ImMucin
Treatment with ImMucin and rhGMCSF (recombinant human granulocyte-monocyte colony stimulating factor)
Biological: ImMucin, hGM-CSF
  • Six biweekly Intradermal or subcutaneous injections of 100 micrograms ImMucin
  • After six injections, if response will not be observed, or if response will not be sufficient, Immucin dose will be escalated to 250 micrograms for six additional injections.
  • In addition, each immunization, hGM-CSF with a total dose of 250 microgram will be injected.

Primary Outcome Measures :
  1. Safety of intradermal or subcutaneous administration of the ImMucin peptide [ Time Frame: 6 months ]

    Determine the safety and initial feasibility of intradermal or subcutaneous administration of the ImMucin peptide combined with hGM-CSF for maximal stimulation of T cell response.

    The patients will receive six or twelve biweekly injections of Imucin (3 or 6 months). Post Treatment visit will be performed 4 weeks after administration of last vaccination. FU telephone calls will be made up to 6 months following the last vaccination in order to assess the status of the disease.

Secondary Outcome Measures :
  1. Assess efficacy of study treatment [ Time Frame: 6 months ]
    Assessment of respose to treatment during treatment period (3 or 6 months).Post Treatment visit will be performed 4 weeks after administration of last vaccination. FU telephone calls will be made up to 6 months following the last vaccination in order to assess the status of the disease.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. All* patients must have a histological or cytological diagnosis of metastatic disease or hematological malignancies expressing the MUC1. Patients must have metastatic disease, and have failed at least one regimen of standard based chemotherapy for metastatic disease as indicated in the following table. Patients must have disease considered to be incurable by surgical or radiological intervention.
  2. Patients must be > 18 years of age, consenting to participate in the study.
  3. Patients must have at least one site of measurable tumor or measurable tumor marker.
  4. Radiological and other relevant imaging studies, such as CT scans, must be performed within 4 weeks of the first treatment as a baseline to document extent of disease.
  5. Patients should be at least 4 weeks beyond any major surgery or chemoradiotherapy and have recovered from drug induced toxicity.
  6. Patients must have a performance status of 70% or greater on the Karnofsky scale (ECOG 0-2) and a minimal life expectancy of 12 months.
  7. Patients must sign an informed consent, and be mentally responsible.

    • In Multiple Myeloma, MUC1 expression will be tested after confirming that all inclusion/exclusion criteria are met and within the screening period.

Exclusion Criteria:

  1. Patients not fulfilling the above criteria.
  2. Patients with a significant concurrent medical complication that in the judgment of the Principal Investigator could affect the patient's ability to tolerate or complete this study.
  3. Patients receiving any immunosuppressive treatment that could negate development of an effective immune response to the vaccine. (First vaccination should be at least 30 days from end of immunosuppressive treatment)
  4. 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 as adjuvant therapy for rectal cancer are not excluded.
  5. 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.
  6. Patients with brain metastasis.
  7. Patients with active infection.
  8. Patients with HIV HBSAg and HCV positive.

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 identifier (NCT number): NCT01232712

Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Vaxil Therapeutics Ltd.
Principal Investigator: Michael Y Shapira, MD Hadassah Medical Organization

Responsible Party: Vaxil Therapeutics Ltd. Identifier: NCT01232712     History of Changes
Other Study ID Numbers: VAXIL-001
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013

Keywords provided by Vaxil Therapeutics Ltd.:
Multiple Myeloma

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