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

NCT ID: NCT02016833

Last Updated: 2015-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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

Keywords

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Ovarian Cancer Cervical Cancer Leukemia Immunity WT-1 Survivin HPV

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Blood Sampling

Intervention Type PROCEDURE

Sampling of 80mL of whole blood

Interventions

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Blood Sampling

Sampling of 80mL of whole blood

Intervention Type PROCEDURE

Eligibility Criteria

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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
* 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

* 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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PX Biosolutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda Mileshkin, MD

Role: PRINCIPAL_INVESTIGATOR

Peter MacCallum Cancer Centre, Australia

Locations

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Peter MacCallum Cancer Center

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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PX_DCtagTM_LeadIn_001

Identifier Type: -

Identifier Source: org_study_id