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

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ClinicalTrials.gov Identifier: NCT00162500

Recruitment Status : Withdrawn

First Posted : September 13, 2005

Last Update Posted : November 10, 2010

Sponsor:

Collaborator:

Vaxil Therapeutics Ltd.

Information provided by:

Hadassah Medical Organization

Tracking Information

First Submitted Date ^ICMJE

September 11, 2005

First Posted Date ^ICMJE

September 13, 2005

Last Update Posted Date

November 10, 2010

Study Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

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 ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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.

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Myeloma
Tumors

Intervention ^ICMJE

Biological: Peptide Vaccine (MUC-1)

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Original Enrollment ^ICMJE

Same as current

Study Completion Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Israel

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00162500

Other Study ID Numbers ^ICMJE

191203-HMO-CTIL

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hadassah Medical Organization

Collaborators ^ICMJE

Vaxil Therapeutics Ltd.

Investigators ^ICMJE

Principal Investigator:

Shimon Slavin, MD

Hadassah Medical Organization

PRS Account

Hadassah Medical Organization

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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