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

Status:

WITHDRAWN

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

Lead Sponsor:

Hadassah Medical Organization

Collaborating Sponsors:

Vaxil Therapeutics Ltd.

Conditions:

Multiple Myeloma

Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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...

Eligibility Criteria

Inclusion

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

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT00162500

Last Update

November 10 2010

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