This is an uncontrolled, mono-centre, phase II single dose trial for patients with ovarian cancer, who have a rising serum tumor marker CA-125 after previous treatment (surgery and platinum based chemotherapy), to determine the clinical effectiveness of a p53 synthetic long peptide vaccine preceded by the administration of cyclophosphamide. MedDRA version: 9.1 Level: LLT Classification code 10033128 Term: Ovarian cancer
Conditions
Interventions
Product Name: p53 synthetic long peptides
Product Code: p53 slp
Pharmaceutical Form: Injection*
Trade Name: Endoxan
Pharmaceutical Form: Intravenous infusion
Sponsors
University Medical Center Groningen, UMCG-Department of Gynaecologic Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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, or 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 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
Exclusion criteria
Exclusion criteria: -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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A) To improve the clinical effectiveness of the p53 synthetic long peptides vaccine in Montanide ISA51 by administration of low dose cyclophosphamide prior to immunisation. B) To improve immunogenicity of the p53 synthetic long peptides vaccine in Montanide ISA51 by administration of low dose cyclophosphamide prior to immunisation ;Secondary Objective: To evaluate the safety of the p53 synthetic long peptide vaccine in combination with a defined adjuvant with known mode of action (Montanide ISA51) when preceded by administration of low dose cyclophosphamide. ;Primary end point(s): A) Clinical responses to the p53 synthetic long peptide vaccine preceded by low-dose cyclophosphamide will be assessed by measurement of serum CA-125 levels and CT-scan. B) Immunogenicity will be evaluated by assessing induction and frequency of p53-specific T cells by proliferation and IFN-? ELISPOT. | — |
Countries
Netherlands
Outcome results
None listed