A Novel Vaccine for the Treatment of MUC1-Expressing Tumor Malignancies - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 11, 2005

Last Updated Date

January 9, 2007

Start Date ^†

Current 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

Original Primary Outcome Measures ^†

Determine the feasibility and safety of intradermal adminisration of the ImMucin peptide combined with GM-CSF for maximal stimulation of the draining lymphnodes.

Change History

Complete list of historical versions of study NCT00162500 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Document development of immune response to the peptide by in-vivo DTH and in-vitro assays and whenever possible, cytotoxic responses mediated by CD8 against HLA identical tumor.

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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 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).

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Condition ^†

Multiple Myeloma
Tumors

Intervention ^†

Biological: Peptide Vaccine (MUC-1)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Shimon Slavin, MD	+972-2-6776561	slavin@hadassah.org.il
Contact: Lior Carmon, PHD, MBA	+972-3-6491190	mkcarmon@inter.net.il

Location Countries ^†

Israel

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00162500

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Hadassah Medical Organization

Collaborators ^††

Vaxil Therapeutics Ltd.

Investigators ^†

Principal Investigator:

Shimon Slavin, MD

Hadassah Medical Organization

Information Provided By

Hadassah Medical Organization

Verification Date

September 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.