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

Primary Purpose

Multiple Myeloma, Tumors

Status
Withdrawn
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Peptide Vaccine (MUC-1)
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Metastatic solid tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Medical Organization

Outcomes

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

Full Information

First Posted
September 11, 2005
Last Updated
November 9, 2010
Sponsor
Hadassah Medical Organization
Collaborators
Vaxil Therapeutics Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00162500
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization
Collaborators
Vaxil Therapeutics Ltd.

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Tumors
Keywords
Metastatic solid tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Peptide Vaccine (MUC-1)
Primary Outcome Measure Information:
Title
Determine the safety and tolerability of vaccination comprising the ImMucin vaccine
Title
combined with Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), in patients
Title
with multiple myeloma and other MUC-1 antigen-expressing metastatic carcinomas
Secondary Outcome Measure Information:
Title
Determine objective anti-tumor response in patients treated with this regimen;
Title
Determine immune response in patients treated with this regimen

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shimon Slavin, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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