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A Study to Assess the Safety and Efficacy of MUC1 Peptide Vaccine and hGM-CSF in Patients With MUC1-positive Tumor Malignancies

NCT01232712 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-08-09

No results posted yet for this study

Summary

The scientific approach behind this study is to develop novel anti-cancer therapeutic vaccine to induce a robust cellular immune response mediated via both CD4+ and CD8+ T lymphocytes populations and can be be applicable to the majority of the target population.

Conditions

Interventions

BIOLOGICAL

ImMucin, hGM-CSF

* Six biweekly Intradermal or subcutaneous injections of 100 micrograms ImMucin * After six injections, if response will not be observed, or if response will not be sufficient, Immucin dose will be escalated to 250 micrograms for six additional injections. * In addition, each immunization, hGM-CSF with a total dose of 250 microgram will be injected.

Sponsors & Collaborators

  • Vaxil Therapeutics Ltd.

    lead INDUSTRY

Principal Investigators

  • Michael Y Shapira, MD · Hadassah Medical Organization

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01232712 on ClinicalTrials.gov