Clinical trial NCT02016833: Development of Immunological Assays for the Evaluation of Tumor Antigen Specific Immunity
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Serous Adenocarcinoma
Undifferentiated Carcinoma of Ovary
Cervical Cancer
Cervical Intraepithelial Neoplasia, Grade 3
Acute Myeloid Leukemia
Chronic Myeloid Leukemia
Keywords: Ovarian Cancer
Cervical Cancer
Leukemia
Immunity
WT-1
Survivin
HPV
Lead sponsor: PX Biosolutions
Sponsor class: INDUSTRY
First posted: 2013-12-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three type of patients will be enrolled in this study:

* Women with a confirmed diagnosis of serous or undifferentiated ovarian cancer
* Women with a confirmed diagnosis of CIN3 or cervical cancer
* HLA-A2 positive men or women with a confirmed diagnosis of AML of CML All these patients will be less than 70 years of age and will show no evidence of active progressive disease on follow up. For ovarian cancer patients, a woman with a rising CA125 and negative imaging is acceptable.

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.


Eligibility criteria: 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
* ECOG 0-2
* 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.

Primary outcomes:
measure: Development and validation of ELISpot and tetramer assays for the detection of tumor-antigen specific T cell immune responses in cancer patients
timeFrame: Baseline
Secondary outcomes:
measure: Characterisation of WT1, Survivin and HPV16 E7 specific immune responses in cancer patients
timeFrame: Baseline
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Center
state: Victoria
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Linda Mileshkin, MD
role: PRINCIPAL_INVESTIGATOR
References: