Development of Immunological Assays for the Evaluation of Tumor Antigen Specific Immunity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02016833|
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : April 30, 2015
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.
|Condition or disease||Intervention/treatment|
|Ovarian Serous Adenocarcinoma Undifferentiated Carcinoma of Ovary Cervical Cancer Cervical Intraepithelial Neoplasia, Grade 3 Acute Myeloid Leukemia Chronic Myeloid Leukemia||Procedure: Blood Sampling|
|Study Type :||Observational|
|Actual Enrollment :||15 participants|
|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|
|Study Start Date :||October 2013|
|Primary Completion Date :||June 2014|
|Study Completion Date :||December 2014|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016833
|Peter MacCallum Cancer Center|
|Melbourne, Victoria, Australia, 3002|
|Principal Investigator:||Linda Mileshkin, MD||Peter MacCallum Cancer Centre, Australia|