A Study to Assess the Safety and Efficacy of MUC1 Peptide Vaccine and hGM-CSF in Patients With MUC1-positive Tumor Malignancies
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|ClinicalTrials.gov Identifier: NCT01232712|
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : August 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: ImMucin, hGM-CSF||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies|
|Study Start Date :||September 2010|
|Primary Completion Date :||May 2013|
|Study Completion Date :||May 2013|
Treatment with ImMucin and rhGMCSF (recombinant human granulocyte-monocyte colony stimulating factor)
Biological: ImMucin, hGM-CSF
- Safety of intradermal or subcutaneous administration of the ImMucin peptide [ Time Frame: 6 months ]
Determine the safety and initial feasibility of intradermal or subcutaneous administration of the ImMucin peptide combined with hGM-CSF for maximal stimulation of T cell response.
The patients will receive six or twelve biweekly injections of Imucin (3 or 6 months). Post Treatment visit will be performed 4 weeks after administration of last vaccination. FU telephone calls will be made up to 6 months following the last vaccination in order to assess the status of the disease.
- Assess efficacy of study treatment [ Time Frame: 6 months ]Assessment of respose to treatment during treatment period (3 or 6 months).Post Treatment visit will be performed 4 weeks after administration of last vaccination. FU telephone calls will be made up to 6 months following the last vaccination in order to assess the status of the disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232712
|Hadassah Medical Center|
|Principal Investigator:||Michael Y Shapira, MD||Hadassah Medical Organization|