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

Sponsor:	Vaxil Therapeutics Ltd.
Information provided by:	Vaxil Therapeutics Ltd.
ClinicalTrials.gov Identifier:	NCT01232712

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Biological: ImMucin, hGM-CSF	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Vaxil Therapeutics Ltd.:

Primary Outcome Measures:

Safety of intradermal or subcutaneous administration of the ImMucin peptide [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

Assess efficacy of study treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	15
Study Start Date:	September 2010
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ImMucin Treatment with ImMucin and rhGMCSF (recombinant human granulocyte-monocyte colony stimulating factor)	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All* patients must have a histological or cytological diagnosis of metastatic disease or hematological malignancies expressing the MUC1. Patients must have metastatic disease, and have failed at least one regimen of standard based chemotherapy for metastatic disease as indicated in the following table. Patients must have disease considered to be incurable by surgical or radiological intervention.
Patients must be > 18 years of age, consenting to participate in the study.
Patients must have at least one site of measurable tumor or measurable tumor marker.
Radiological and other relevant imaging studies, such as CT scans, must be performed within 4 weeks of the first treatment as a baseline to document extent of disease.
Patients should be at least 4 weeks beyond any major surgery or chemoradiotherapy and have recovered from drug induced toxicity.
Patients must have a performance status of 70% or greater on the Karnofsky scale (ECOG 0-2) and a minimal life expectancy of 12 months.
Patients must sign an informed consent, and be mentally responsible.
- In Multiple Myeloma, MUC1 expression will be tested after confirming that all inclusion/exclusion criteria are met and within the screening period.

Exclusion Criteria:

Patients not fulfilling the above criteria.
Patients with a significant concurrent medical complication that in the judgment of the Principal Investigator could affect the patient's ability to tolerate or complete this study.
Patients receiving any immunosuppressive treatment that could negate development of an effective immune response to the vaccine. (First vaccination should be at least 30 days from end of immunosuppressive treatment)
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 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 metastasis.
Patients with active infection.
Patients with HIV HBSAg and HCV positive.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232712

Contacts

Contact: Lior Carmon, PhD	+972 8 9396948	lior.carmon@vaxilbio.com
Contact: Ofira Moran, PhD	+972 54 7718216	Ofira.moran@vaxilbio.com

Locations

Israel
Hadassah Medical Center	Recruiting
Jerusalem, Israel
Contact: Michael Y Shapira, Dr +972-2-6778357 shapiram@hadassah.org.il
Contact: Liliane Dray +972-2-6777260 LILANE@hadassah.org.il
Principal Investigator: Michael Shapira, MD

Sponsors and Collaborators

Vaxil Therapeutics Ltd.

Investigators

Principal Investigator:

Michael Y Shapira, MD

Hadassah Medical Organization

More Information

Additional Information:

Vaxil BioTherapeutics Ltd. web site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dr Lior Carmon/ Founder & CEO, Vaxil Biotherapeutics Ltd.
ClinicalTrials.gov Identifier:	NCT01232712 History of Changes
Other Study ID Numbers:	VAXIL-001
Study First Received:	October 22, 2010
Last Updated:	June 9, 2011
Health Authority:	Israel: Ministry of Health

Keywords provided by Vaxil Therapeutics Ltd.:

MUC1
ImMucin
Vaccine
Multiple Myeloma

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases

Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2012