p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer

Study Overview
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Brief Summary
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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.

Official Title
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p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer a Phase II Trial

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: P53-SLP vaccine
* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: P53-SLP vaccine|The P53-SLP vaccine is a vaccine consisting of a total of 10 long (30 amino acids on average length) peptides, covering the p53 protein sequence from amino acid 70 to 251, combined with Montanide ISA51 an adjuvant with a sustained dendritic cell activating ability. Patients will be immunised subcutaneously with the peptide vaccine four times with a three week interval (300μg/peptide).|
|Drug: Cyclophosphamide|Two days prior to each peptide vaccination, patients will receive 300mg/m2 cyclophosphamide i.v.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian cancer patients with recurrent disease