Trial | NCT00844506  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    19
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.
Study Started
Oct 31
2008
Primary Completion
Jul 31
2009
Study Completion
Jul 31
2009
Last Update
Feb 25
2011
Estimate

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.

  • Other names: Endoxan, Cytoxan

Criteria 

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).
No Results Posted