|- candidate number||3831|
|- NTR Number||NTR1407|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-aug-2008|
|- Secondary IDs||2007-007734-19 Eudract number|
|- Public Title||Investigation of the treatment of ovarian cancer with p53-peptide vaccination after pretreatment with cyclofosfamide|
|- Scientific Title||p53 synthetic long peptide vaccine with cyclofosfamide for ovarian cancer, a phase II trial|
|- Healt Condition(s) or Problem(s) studied||Ovarian cancer, Vaccination, Cyclofosfamide|
|- Inclusion criteria||1. Histological proven epithelial ovarian carcinoma. |
2. At least 4 weeks after termination of the last course of chemotherapy.
3. Rising CA-125 serum levels after “first line” treatment and no measurable disease according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria,
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.
4. Age 18 years or older, and an life expectancy of at least 3 months.
5. 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.
6. Performance status 0 to 2 (WHO scale).
7. 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 ìmol/l; WBC > 3.0 x 109/L; platelets > 100 x 109/L; hemoglobin > 6.0 mmol/l.
8. Adequate venous access for blood collection and i.v. administration of cyclophosphamide.
|- Exclusion criteria||1. (A)symptomatic cystitis|
2. Other malignancies (previous or current), except basal or squamous cell carcinoma of the skin.
3. Immunosuppressive agents, except for topical and inhalation corticosteroids.
4. Prior therapy with a biological response modifier.
5. Participation in any other trial with an investigational drug.
6. 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).
7. Signs or symptoms of CNS metastases.
8. Known substance abuse (drug or alcohol).
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-sep-2008|
|- planned closingdate||31-dec-2009|
|- Target number of participants||19|
|- Interventions||-p53 synthetic long peptides in Montanide ISA51.
-cyclophosphamide i.v. (300mg/m2)
|- Primary outcome||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. |
B) Immunogenicity will be evaluated by assessing induction and frequency of p53-specific T cells by proliferation and IFN-ã ELISPOT.
|- Secondary outcome||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.|
|- Timepoints||Two days prior to each peptide vaccination (300ìg/peptide), patients will receive 300mg/m2 cyclophosphamide i.v. Patients will be immunised subcutaneously with the peptide vaccine four times with a three week interval. For the isolation of PBMC 150 ml of blood will be obtained before the first, and 100 ml before the third and three weeks after the fourth administration of cyclophosphamide. An additional 10 ml will be collected on each immunisation day to ascertain the effect of cyclophosphamide on regulatory T-cells. Before the third and three weeks after the last administration of cyclophosphamide, a skin biopsy will be taken from the most recent vaccination site. Serum will be obtained before the first (30 ml) and three weeks after the last (10 ml) administration of cyclophosphamide.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. N. Leffers|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. H.W. Nijman|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|Dutch Cancer Society, Isa pharmaceuticals B.V.|
|- Brief summary||This is an uncontrolled, mono-centre, phase II trial for patients with ovarian cancer, who have a rising serum tumor marker CA-125 after previous treatment (surgery and platinum based chemotherapy), to determine the clinical effectiveness of a p53 synthetic long peptide vaccine preceded by the administration of cyclophosphamide. After 10 patients, an interim analysis will be performed.|
|- Main changes (audit trail)|
|- RECORD||15-aug-2008 - 29-okt-2008|