Recurrent ovarian cancer Recidief ovariumcarcinoom
Conditions
Interventions
-p53 synthetic long peptides in Montanide ISA51.
-cyclophosphamide i.v. (300mg/m2)
Sponsors
UMCG
Eligibility
Inclusion criteria
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, 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. 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 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | 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. | — |
Contacts
Public ContactN. Leffers
Universitair Medisch Centrum Groningen Afd. Gynaecologische Oncologie (CB22) Postbus 30.001
Outcome results
None listed