p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer

Phase 2

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT00844506
• Lead Sponsor: University Medical Center Groningen

Brief Summary

The purpose of this study is to determine whether the addition of cyclophosphamide to the treatment with the p53-SLP vaccine improves clinical efficacy and immunogenicity of the p53-SLP vaccine in ovarian cancer patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-24
• Last Update Posted: 2011-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• 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.
• 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.

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.
• 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: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical responses to the p53 synthetic long peptide vaccine preceded by cyclophosphamide will be assessed by measurement of serum CA-125 levels and CT-scan.	day 105 - 126 after first gift of cyclophosphamide
Immunogenicity will be evaluated by assessing induction and frequency of p53-specific T cells by proliferation and IFN-γ ELISPOT.	after fourth immunization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands