A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies
Sponsor study identifier
interventional
15
1 country
1
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2013
Actual (reported)Study Completion
May 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
October 22, 2010
Actual (reported)November 2, 2010
Actual (reported)May 2013
Actual (reported)May 2013
Actual (reported)Safety of intradermal or subcutaneous administration of the ImMucin peptide
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.
6 months
Assess efficacy of study treatment
6 months
Treatment with ImMucin and rhGMCSF (recombinant human granulocyte-monocyte colony stimulating factor)
* 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hadassah Medical Center
Jerusalem, Israel
Michael Y Shapira, MD
Hadassah Medical Organization
15 participants (actual enrollment reported by the registry).
First Submitted
October 22, 2010
First Posted
November 2, 2010
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2013
Actual (reported)Study Completion
May 2013
Actual (reported)Last Updated
August 9, 2013
Record last verified: 2013-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: