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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

NCT ID: NCT01232712

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Keywords

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MUC1 ImMucin Vaccine Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ImMucin

Treatment with ImMucin and rhGMCSF (recombinant human granulocyte-monocyte colony stimulating factor)

Group Type EXPERIMENTAL

ImMucin, hGM-CSF

Intervention Type BIOLOGICAL

* 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Patients must be \> 18 years of age, consenting to participate in the study.
3. Patients must have at least one site of measurable tumor or measurable tumor marker.
4. 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.
5. Patients should be at least 4 weeks beyond any major surgery or chemoradiotherapy and have recovered from drug induced toxicity.
6. 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.
7. Patients must sign an informed consent, and be mentally responsible.

Exclusion Criteria

1. Patients not fulfilling the above criteria.
2. 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.
3. 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)
4. 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.
5. 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.
6. Patients with brain metastasis.
7. Patients with active infection.
8. Patients with HIV HBSAg and HCV positive.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vaxil Therapeutics Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Y Shapira, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Related Links

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http://www.vaxilbio.com

Vaxil BioTherapeutics Ltd. web site

Other Identifiers

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VAXIL-001

Identifier Type: -

Identifier Source: org_study_id