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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02016833




Registration number
NCT02016833
Ethics application status
Date submitted
5/12/2013
Date registered
20/12/2013
Date last updated
30/04/2015

Titles & IDs
Public title
Development of Immunological Assays for the Evaluation of Tumor Antigen Specific Immunity
Scientific 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
Secondary ID [1] 0 0
PX_DCtagTM_LeadIn_001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Serous Adenocarcinoma 0 0
Undifferentiated Carcinoma of Ovary 0 0
Cervical Cancer 0 0
Cervical Intraepithelial Neoplasia, Grade 3 0 0
Acute Myeloid Leukemia 0 0
Chronic Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Blood Sampling

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


Treatment: Surgery: Blood Sampling
Sampling of 80mL of whole blood
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Development and validation of ELISpot and tetramer assays for the detection of tumor-antigen specific T cell immune responses in cancer patients
Timepoint [1] 0 0
Baseline
Secondary outcome [1] 0 0
Characterisation of WT1, Survivin and HPV16 E7 specific immune responses in cancer patients
Timepoint [1] 0 0
Baseline

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
PX Biosolutions
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02016833
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Linda Mileshkin, MD
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries