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

April 29, 2015 updated by: PX Biosolutions

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • Peter MacCallum Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer patients
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
Procedure: Blood Sampling
Sampling of 80mL of whole blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PX Biosolutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 15, 2013

First Posted (ESTIMATE)

December 20, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PX_DCtagTM_LeadIn_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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