Development of Immunological Assays for the Evaluation of Tumor Antigen Specific Immunity
This study is a clinical study aiming at establishing immunological assays for the qualitative and quantitative evaluation of WT-1, Survivin and HPV16 E7-specific immune responses in cancer patients. Such a study will allow the development of suitable immunological tools to be used in assessing response in a subsequent phase I study aiming at evaluating therapeutic vaccine candidates targeting WT-1, Survivin and/or HPV16 E7-expressing tumors. In addition, this study will help defining the baseline cancer-associated immune responses in the selected patient population.
Cervical and ovarian cancer patients, as well as leukemia patients, will be included in this study.
WT-1, Survivin and HPV-specific immune responses will be monitored in these patients by ex vivo and cultured IFNg ELISpot as well as tetramer staining.
|Ovarian Serous Adenocarcinoma Undifferentiated Carcinoma of Ovary Cervical Cancer Cervical Intraepithelial Neoplasia, Grade 3 Acute Myeloid Leukemia Chronic Myeloid Leukemia||Procedure: Blood Sampling|
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Phase 0 Study for the Development of Immunological Assays for the Evaluation of WT-1, Survivin and HPV16 E7 Tumor Antigens Specific Immune Responses in Cancer Patients|
- Development and validation of ELISpot and tetramer assays for the detection of tumor-antigen specific T cell immune responses in cancer patients [ Time Frame: Baseline ]Direct and cultured IFNg ELISpot as well as direct tetramer staining assays will be set up and qualified for the detection WT-1, survivin and HPV16 E7 specific immune responses in cancer patients
- Characterisation of WT1, Survivin and HPV16 E7 specific immune responses in cancer patients [ Time Frame: Baseline ]Direct and Cultured IFNg ELISpot assays as well as tetramer staining assays will be used for the characterization of tumor specific immune responses in cancer patients
Biospecimen Retention: Samples With DNA
|Study Start Date:||October 2013|
|Study Completion Date:||December 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Patient with histologically confirmed diagnosis of cervical cancer or cervical intraepithelial neoplasia (grade 3) or of high-grade serous (or undifferentiated) ovarian cancer or patients with AML or CML confirmed by bone marrow biopsy or peripheral blood Not treated - prior standard of care therapy acceptable one blood sampling performed on the visit day
Procedure: Blood Sampling
Sampling of 80mL of whole blood
Please refer to this study by its ClinicalTrials.gov identifier: NCT02016833
|Peter MacCallum Cancer Center|
|Melbourne, Victoria, Australia, 3002|
|Principal Investigator:||Linda Mileshkin, MD||Peter MacCallum Cancer Centre, Australia|