 |
|
A Novel Vaccine for the Treatment of MUC1-Expressing Tumor Malignancies
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Treatment | Approved-not yet active | Over 18 | 191203-HMO-CTIL
NCT00162500 |
Trial Description
Summary Rationale: ImMucin was shown to be able to induce a robust cellular immune response mediated via both CD4+ and CD8+ T lymphocytes and therefore, could potentially be more effective in the majority of the target population. Purpose: The purpose of this study is to evaluate the safety and initial efficacy of ImMucin, a novel peptide vaccine in metastatic tumors expressing the MUC-1 Tumor Associated Antigen (TAA). Eligibility Criteria Inclusion Criteria: - All patients must have a histological or cytological diagnosis of metastatic disease expressing the MUC-1. Patients must have metastatic disease and have failed at least one regimen of standard based chemotherapy for metastatic disease such as:
- Renal Cell Carcinoma (RCC),
- Transitional Cell Carcinoma (TCC),
- Patients must be >18 years of age, consenting to participation in the study.
- Patients must have at least one site of measurable tumor or measurable tumor marker.
Exclusion Criteria: - Patients receiving any immunosuppressive treatment that could negate development of an effective immune response to the vaccine.
- 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 such 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 metastases.
- Patients with active infection.
- Patients with HIV hepatitis B surface antigen (HBS Ag) and hepatitis C virus (HCV) positive patients.
Trial Contact Information
Trial Lead Organizations/Sponsors Hadassah University Hospital Vaxil Bio Therapeutics, Incorporated
| Shimon Slavin, MD | | Principal Investigator |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00162500
Information obtained from ClinicalTrials.gov on May 13, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
Back to Top |
|
