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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00162500
• Other study ID #: 191203-HMO-CTIL
• Status: Withdrawn
• Phase: Phase 2
• First received: September 11, 2005
• Last updated: November 9, 2010

Study information

• Verified date: September 2005
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 15
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Tumors

Intervention

Biological:
• Peptide Vaccine (MUC-1)

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Vaxil Therapeutics Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the safety and tolerability of vaccination comprising the ImMucin vaccine
Primary	combined with Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), in patients
Primary	with multiple myeloma and other MUC-1 antigen-expressing metastatic carcinomas
Secondary	Determine objective anti-tumor response in patients treated with this regimen;
Secondary	Determine immune response in patients treated with this regimen