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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ImMucin | Experimental | Treatment with ImMucin and rhGMCSF (recombinant human granulocyte-monocyte colony stimulating factor) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ImMucin, hGM-CSF | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Y Shapira, MD | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Jerusalem | Israel |
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| Label | URL |
|---|---|
| Vaxil BioTherapeutics Ltd. web site | View source |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |