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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 19

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.
-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.

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Clinical response after treatment with the p53 synthetic long peptides vaccine<br /><br>preceded by administration of cyclophosphamide will be evaluated by serum<br /><br>CA-125 levels and tumour volume with CT-scan.<br /><br><br /><br>Immunogenicity of the vaccine when preceded by cyclophosphamide, will be<br /><br>determined by assessment of the induction and frequency of p53-specific T cells<br /><br>following vaccination by proliferation and IFN-γ ELISPOT.<br /><br><br /><br>The effect of addition of cyclophosphamide to the regimen will be determined by<br /><br>comparing the responses elicited in the present study with those from the<br /><br>previous study for all endpoints.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety of the vaccine preceded by cyclophosphamide will be assessed by<br /><br>monitoring the incidence and severity of adverse events using Common<br /><br>Terminology Criteria for Adverse Events v3.0.</p><br>