DC for endometrial cancer patients

Phase 1

• Conditions: metastatic endometrial cancer; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-004467-31-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-13
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

women = 18 years old with histologically confirmed stage IV or metastatic carcinoma of the endometrium of the endometroid, serous or carcinosarcoma type.
•Hormone receptor negative or
oresistant to hormonal therapy
oineligible for hormonal therapy because of other reasons
•eligible for treatment with carboplatin paclitaxel combination chemotherapy
•Life expectancy = 6 months
•WHO/ECOG performance status 0-1 (Karnofsky index 100-70)
•WBC >2.0?109/l, neutrophils >1.5?109/L lymphocytes >0.8?109/L, platelets >100?109/L, hemoglobin >5,6 mmol/L (9.0 g/dL), serum creatinine <150 µmol/L, AST/ALT <3 x ULN, serum bilirubin <1.5 x ULN (exception: Gilbert’s syndrome is permitted)
•Expression of survivin and/or muc1 on tumor material
•Expected adequacy of follow-up
•Postmenopausal or evidence of non-childbearing status or for women of childbearing potential: negative urine or serum pregnancy test, within 28 days of study treatment and confirmed prior to treatment on day 1
•Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

•Eligible for hormonal therapy
•Uncontrolled hypercalcemia
•History of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma
•Known allergy to shell fish
•Heart failure (NYHA class III/IV)
•Serious active infections
•Active hepatitis B, C or HIV infection
•Active syphilis infection
•Autoimmune diseases (exception: vitiligo is permitted)
•Organ allografts
•An uncontrolled co-morbidity, e.g. psychiatric or social conditions interfering which participation
•Concurrent use of systemic corticosteroids > 10 mg daily prednisone equivalent
•Any serious clinical condition that may interfere with the safe administration of DC vaccinations
•Unable to undergo a tumor biopsy
•Pregnancy or insufficient anti-conception if reproduction is still possible

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified