Investigation of the treatment of ovarian cancer with p53-peptide vaccination after pretreatment with cyclofosfamide

Recruiting

• Conditions: Recurrent ovarian cancerRecidief ovariumcarcinoom

• Registration Number: NL-OMON27620
• Lead Sponsor: MCG

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 19

Inclusion Criteria

1. Histological proven epithelial ovarian carcinoma.

2. At least 4 weeks after termination of the last course of chemotherapy.

Exclusion Criteria

1. (A)symptomatic cystitis

2. Other malignancies (previous or current), except basal or squamous cell carcinoma of the skin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A) 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. <br /><br>B) Immunogenicity will be evaluated by assessing induction and frequency of p53-specific T cells by proliferation and IFN-ã ELISPOT.<br>

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.