Cell based treatment for patients with ovarian cancer

Phase 1

• Conditions: Advanced Ovarian Cancer; MedDRA version: 18.0Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000530-30-DK
• Lead Sponsor: Center for Cancer Immune Therapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-09
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Histological proven advanced ovarian cancer with the possibility of surgical removal of tumor tissue of > 1 cm3. Histology must be high grade serous carcinoma.
2. Progressive or recurrent resistant disease after platin-based chemotherapy or progressive or recurrent disease after second line or additional chemotherapy
3. Age: 18 – 70 years
4. ECOG performance status of =1
5. Life expectancy of > 6 months
6. At least one measurable parameter in accordance with RECIST 1.1 –criteria’s
7. No significant toxicities or side effects (CTC = 1) from possible previous treatments, except sensoric- and motoric neuropathy (CTC = 2) and/or alopecia (CTC = 2).
8. Sufficient organ function.
9. Women in the fertile age must use effective contraception. This applies from inclusion and until 6 months after treatment.
10. Signed statement of consent after receiving oral and written study information
11. Willingness to participate in the planned controls and capable of handling toxicities.
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 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1. Patients with other cancers within 5 years.
2. Known hypersensitivity to one of the active drugs or one or more of the excipients.
3. Serious comorbidity or autoimmune disease.
4. Creatinine clearence < 70 ml/min (in selected cases it can be decided to include patients with a lower GFR with the use of a reduced dose of chemotherapy).
5. Acutte/chronic infection with HIV, hepatitis, tuberculosis among others.
6. Severe allergies or previous anaphylactic reactions.
7. Pregnant women and women breastfeeding.
8. Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone, metothrexate among others).
9. Simultaneous treatment with other experimental drugs.
10. Simultaneous treatment with other systemic anti-cancer treatments.
11. Patients with active and uncontrollable hypercalcaemia.

Study & Design

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