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

Acute Myeloid Leukemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016833
• Other study ID #: PX_DCtagTM_LeadIn_001
• Status: Completed
• Phase: N/A
• First received: December 5, 2013
• Last updated: April 29, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: PX Biosolutions
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Adenocarcinoma
• Carcinoma
• Carcinoma in Situ
• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Cervical Intraepithelial Neoplasia, Grade 3
• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Ovarian Neoplasms
• Ovarian Serous Adenocarcinoma
• Undifferentiated Carcinoma of Ovary
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Blood Sampling
Sampling of 80mL of whole blood

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Center	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
PX Biosolutions

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development and validation of ELISpot and tetramer assays for the detection of tumor-antigen specific T cell immune responses in cancer patients	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	No
Secondary	Characterisation of WT1, Survivin and HPV16 E7 specific immune responses in cancer patients	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	No