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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of intradermal or subcutaneous administration of the ImMucin peptide

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Michael Y Shapira, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization


Israel: Ministry of Health

Study ID:




Start Date:

September 2010

Completion Date:

February 2013

Related Keywords:

  • Multiple Myeloma
  • MUC1
  • ImMucin
  • Vaccine
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell