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

Completed

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

• Registration Number: NCT02016833
• Lead Sponsor: PX Biosolutions

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-15
• Study First Posted: 2013-12-20
• Primary Completion: 2014-06
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer patients	Blood Sampling	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

Primary Outcome Measures

Name	Time	Method
Development and validation of ELISpot and tetramer assays for the detection of tumor-antigen specific T cell immune responses in cancer patients	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 Outcome Measures

Name	Time	Method
Characterisation of WT1, Survivin and HPV16 E7 specific immune responses in cancer patients	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

Trial Locations

Locations (1)

Peter MacCallum Cancer Center; 🇦🇺 Melbourne, Victoria, Australia