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

P

PX Biosolutions

Status

Completed

Conditions

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

Treatments

Procedure: Blood Sampling

Study type

Observational

Funder types

Industry

Identifiers

NCT02016833
PX_DCtagTM_LeadIn_001

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

15 participants in 1 patient group

Cancer patients
Description:
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:
Procedure: Blood Sampling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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