Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02016833