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

niversity Medical Center Groningen, UMCG-Department of Gynaecologic Oncology0 个研究点目标入组 19 人开始时间: 2008年1月7日最近更新: 2023年1月9日

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.
•-Age 18 years or older, and an life expectancy of at least 3 months
•-Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
•-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.
•-Adequate venous access for blood collection and i.v. administration of cyclophosphamide.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-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

niversity Medical Center Groningen, UMCG-Department of Gynaecologic Oncology