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

NCT02016833 | Completed

• 1 other identifier: PX_DCtagTM_LeadIn_001
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Ovarian Cancer; Cervical Cancer; Leukemia; Immunity; WT-1; Survivin; HPV

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Characterisation of WT1, Survivin and HPV16 E7 specific immune responses in cancer patients

  Baseline

Study Arms (1)

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

Interventions

Blood Sampling PROCEDURE

Sampling of 80mL of whole blood

Cancer patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• PX Biosolutions: lead

Study Sites (1)

Peter MacCallum Cancer Center

Melbourne, Victoria, 3002, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

PBMCs isolated from whole blood

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Ovarian Neoplasms; Leukemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions; Leukemia, Myeloid; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Linda Mileshkin, MD

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 20, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 30, 2015

Record last verified: 2015-04

Locations

AU (1)