Back to resultsA Study to Assess the Safety and Efficacy of MUC1 Peptide Vaccine and hGM-CSF in Patients With MUC1-positive Tumor Malignancies
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
ImMucin, hGM-CSF
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring MUC1, ImMucin, Vaccine, Multiple Myeloma
Eligibility 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.
Sites / Locations
- Hadassah Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ImMucin
Arm Description
Treatment with ImMucin and rhGMCSF (recombinant human granulocyte-monocyte colony stimulating factor)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Assess efficacy of study treatment
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.
Full Information
NCT ID
NCT01232712
First Posted
October 22, 2010
Last Updated
August 6, 2013
Sponsor
Vaxil Therapeutics Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01232712
Brief Title
A Study to Assess the Safety and Efficacy of MUC1 Peptide Vaccine and hGM-CSF in Patients With MUC1-positive Tumor Malignancies
Official Title
A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vaxil Therapeutics Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
MUC1, ImMucin, Vaccine, Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ImMucin
Arm Type
Experimental
Arm Description
Treatment with ImMucin and rhGMCSF (recombinant human granulocyte-monocyte colony stimulating factor)
Intervention Type
Biological
Intervention Name(s)
ImMucin, hGM-CSF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety of intradermal or subcutaneous administration of the ImMucin peptide
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Assess efficacy of study treatment
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Y Shapira, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Links:
URL
http://www.vaxilbio.com
Description
Vaxil BioTherapeutics Ltd. web site
Learn more about this trial
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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