NL-OMON46501
Recruiting
Not Applicable
Adoptive T cell therapy in patients with recurrent ovarian cancer - OVACURE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 12
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>\= 18 years.
- •OVACURE: Histologically proven epithelial ovarian cancer (EOC). Pre\-OVACURE: Patients with stage IIIc or IV EOC that are treated with first line surgery can participate in the pre\-OVACURE for TIL preservation out of the surgical specimen. In case of recurrent disease these TILs can be used.
- •Recurrent ovarian cancer
- •Presence of measurable progressive disease according to RECIST version 1\.1 or
- •elevated CA125\>2 times the upper normal limit (UNL) within 3 months and confirmed.
- •Expected survival of at least 3 months.
- •WHO performance status 0\-2\.
- •Within the last 2 weeks prior to study day 0, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified:
- •Hemoglobin \>\= 6,0 mmol/l
- •Granulocytes \>\= 1,500/µl
Exclusion Criteria
- •Patients with brain metastases.
- •Clinically significant heart disease (NYHA Class III or IV).
- •Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study.
- •Active immunodeficiency disease or autoimmune disease requiring immune suppressive drugs. Vitiligo is not an exclusion criterion.
- •Other malignancy within 2 years prior to entry into the study, except for treated non\-melanoma skin cancer and premalignant diseasein.
- •Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- •Lack of availability for follow\-up assessments.
- •Pregnancy or breastfeeding
Outcomes
Primary Outcomes
Not specified
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