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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma, Tumors

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the safety and tolerability of vaccination comprising the ImMucin vaccine

Principal Investigator

Shimon Slavin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

191203-HMO-CTIL

NCT ID:

NCT00162500

Start Date:

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Tumors
  • Metastatic solid tumors
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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