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

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.

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Key information

Conditions

Ovarian Serous Adenocarcinoma Acute Myeloid Leukemia Adnexal Diseases Bone Marrow Diseases Cervical Cancer Cervical Intraepithelial Neoplasia, Grade 3 Chronic Disease Chronic Myeloid Leukemia Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Undifferentiated Carcinoma of Ovary Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peter MacCallum Cancer Center

Melbourne, Victoria, 3002, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sampling

Procedure

Sampling of 80mL of whole blood

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

PX Biosolutions

Industry

Registry information

Official study 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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Dec 20, 2013
Registry last updated: Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed