p53 synthetic long peptides vaccine with cyclophosphamide for ovarian cancer, a phase II trial. - ISA-p53-CTX

niversitair Medisch Centrum Groningen0 个研究点目标入组 19 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•-Written informed consent.
•-Histological proven epithelial ovarian carcinoma
•-At least 4 weeks after termination of the last course of chemotherapy.
•-Rising CA-125 serum levels after *first line* treatment and no measurable disease according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria,
•Rising CA-125 serum levels after *first line* treatment with measurable disease according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria, but not willing or otherwise not fit to receive *second line* chemotherapy.
•-18 years or older, and an life expectancy of at least 3 months
•-Performance status 0 to 2 (WHO scale).
•-Adequate hepatic, renal, and bone marrow function as defined:
•ASAT <100 U/l; ALAT <113 U/l; PT 9-12 seconds; APTT 23-33 seconds; creatinine < 135 µmol/l; WBC > 3.0 x 109/L; platelets > 100 x 109/L; hemoglobin > 6.0 mmol/l.

•-Pregnancy and / or breast feeding.
•-(A)symptomatic cystitis
•-Other malignancies (previous or current), except basal or squamous cell carcinoma of the skin.
•-Immunosuppressive agents, except for topical and inhalation corticosteroids.
•-Prior therapy with a biological response modifier.
•-Participation in any other trial with an investigational drug.
•-Any other major disease that may interfere with the conduct of the study (e.g. uncontrolled hypertension, severe and/or unstable heart disease, neurological and psychiatric disorders).
•-Signs or symptoms of CNS metastases.
•-Known substance abuse (drug or alcohol).

发起方