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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Development and validation of ELISpot and tetramer assays for the detection of tumor-antigen specific T cell immune responses in cancer patients
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Specific Inclusion criteria
- •For ovarian cancer patients: Histologically confirmed surgical diagnosis of high-grade serous (or undifferentiated) ovarian cancer
- •For CIN3 and cervical cancer patients: Histologically confirmed diagnosis of CIN3 or cervical cancer
- •For AML and CML patients: HLA-A2 positivity and diagnosis of AML or CML confirmed by bone marrow biopsy or peripheral blood
- •Shared inclusion criteria
- •No evidence of active progressive disease. For ovarian cancer patients, a woman with a rising CA125 and negative imaging is acceptable
- •Age ≥ 18 yrs and < 70 yrs
- •Adequate hematologic assessment (results from the previous standard of care visit):
- •Absolute neutrophil count (ANC) greater than or equal to 1.0 x 109/L
- •Platelets greater than or equal to 100 x 109/L.
- •Written informed consent
Exclusion Criteria
- •Treatment with chemotherapy, radiation therapy, other immunotherapy or non-topical steroids within the past 3 weeks prior to initiation of the study.
- •Immunosuppressive therapy (excluding topical steroids) for any other condition.
- •Recurrent/progressive disease confirmed clinically, radiologically or histologically before entry into the study. (exclude versus inclusion criteria)
- •Persistent fever (>24 hours) documented by repeated measurement or active uncontrolled infection in the last 4 weeks.
- •Active autoimmune disease, including, but not limited to, SLE, MS, ankylosing spondylitis.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Characterisation of WT1, Survivin and HPV16 E7 specific immune responses in cancer patients(Baseline)