Chemo-Immunotherapy, gemcitabine with pegylated interferon alpha-2b (Peg-Intron) with and without p53 synthetic long peptide (p53 SLP) vaccine, for patients with platinum resistant ovarian cancer.CHIP trial - CHIP trial

Phase 1

• Conditions: Recurrent platinum resistant, p53 positive ovarian cancer.; MedDRA version: 12.1Level: LLTClassification code 10066697Term: Ovarian cancer recurrent

• Registration Number: EUCTR2010-023124-24-NL
• Lead Sponsor: Academisch Ziekenhuis Leiden acting under the name of Leids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-04
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Histologically proven epithelial ovarian cancer, peritoneal cavity or fallopian tube cancer (inclusive mucinous or clear cell tumors)
• Tumor expressing p53
• Progression of disease or relapse after previous therapy with platinum
• Measurable disease (RECIST 1.1) or elevated CA125 > 2 times the upper limit of normal within 3 months and confirmed
• Age =18 years
• WHO performance status 0-2
• Adequate bone marrow function: WBC =3.0 x 109/l, neutrophils =1.5 x 109/l, platelets =100 x 109/l
• Adequate liver function: bilirubin =1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT =2.5 x UNL, Alkaline Phosphatase =5 x UNL
• Adequate renal function: the calculated creatinine clearance should be =50 mL/min
• Survival expectation > 3 months
• Patients must be accessible for treatment and follow-up
• Written informed consent according to the local Ethics Committee requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
• Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
• Known hypersensitivity reaction to any of the components of the treatment
• Pregnancy or lactating
• Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine the feasibility to combine gemcitabine and Peg-intron with and without p53-SLP vaccination;Secondary Objective: • The effect of chemo-immunotherapy on the immune system by assessing changes in plasma signature, dendritic cell phenotype and T- and B-cell responses to known tumor antigens in ovarian cancer (eg p53) or antibodies to antigens associated with immunogenic cell death and in tumor tissue by gene array and PCR<br>• The relation between anti-tumor immunity and clinical outcome (response (RECIST 1.1), progression free survival and overall survival)<br>;Primary end point(s): Feasibility of combining gemcitabine with interferon alpha and p53-vaccine in patients with recurrent ovarian cancer