Status:
COMPLETED
p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
ISA Pharmaceuticals B.V.
Dutch Cancer Society
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 ova...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00844506
Start Date
October 1 2008
End Date
July 1 2009
Last Update
February 25 2011
Active Locations (1)
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1
University Medical Centre Groningen
Groningen, Provincie Groningen, Netherlands, 9700 RB