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

This study has been withdrawn prior to enrollment.

First Received on September 11, 2005. Last Updated on November 9, 2010 History of Changes

Sponsor:	Hadassah Medical Organization
Collaborator:	Vaxil Therapeutics Ltd.
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00162500

Purpose

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).

Condition	Intervention	Phase
Multiple Myeloma Tumors	Biological: Peptide Vaccine (MUC-1)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Determine objective anti-tumor response in patients treated with this regimen;
Determine immune response in patients treated with this regimen

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162500

Locations

Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120

Sponsors and Collaborators

Hadassah Medical Organization

Vaxil Therapeutics Ltd.

Investigators

Principal Investigator:

Shimon Slavin, MD

Hadassah Medical Organization

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00162500 History of Changes
Other Study ID Numbers:	191203-HMO-CTIL
Study First Received:	September 11, 2005
Last Updated:	November 9, 2010
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

Metastatic solid tumors

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases

Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2012