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Completed

NCT Number: NCT01232712

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hadassah Medical Center

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Safety of intradermal or subcutaneous administration of the ImMucin peptide

    Time frame: 6 months

    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 outcomes

  1. Assess efficacy of study treatment

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Vaxil Therapeutics Ltd.

Industry

Registry information

Official study title

A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 2, 2010
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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