Trials / Completed
CompletedNCT02016833
Development of Immunological Assays for the Evaluation of Tumor Antigen Specific Immunity
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 15 (actual)
- Sponsor
- PX Biosolutions · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Ovarian Serous Adenocarcinoma
- Undifferentiated Carcinoma of Ovary
- Cervical Cancer
- Cervical Intraepithelial Neoplasia, Grade 3
- Acute Myeloid Leukemia
- Chronic Myeloid Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Blood Sampling | Sampling of 80mL of whole blood |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2014-06-01
- Completion
- 2014-12-01
- First posted
- 2013-12-20
- Last updated
- 2015-04-30
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT02016833. Inclusion in this directory is not an endorsement.