Development of Immunological Assays for the Evaluation of Tumor Antigen Specific Immunity

PX Biosolutions

Status: Completed

Conditions: Cervical Intraepithelial Neoplasia, Grade 3; Chronic Myeloid Leukemia; Acute Myeloid Leukemia; Cervical Cancer; Ovarian Serous Adenocarcinoma; Undifferentiated Carcinoma of Ovary

Treatments: Procedure: Blood Sampling

Study type: Observational

Funder types: Industry

Identifiers

NCT02016833

PX_DCtagTM_LeadIn_001

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 1 patient group

Cancer patients

Description:

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

Treatment:

Procedure: Blood Sampling