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

NCT01232712 | Completed Phase 1

• 1 other identifier: VAXIL-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

MUC1; ImMucin; Vaccine; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Assess efficacy of study treatment

  6 months

Study Arms (1)

ImMucin

EXPERIMENTAL

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

Biological: ImMucin, hGM-CSF

Interventions

ImMucin, hGM-CSF 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.

ImMucin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vaxil Therapeutics Ltd.: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

Location

Related Links

• Vaxil BioTherapeutics Ltd. web site

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Michael Y Shapira, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: November 2, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 9, 2013

Record last verified: 2013-08

Locations

IL (1)