p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer (ISA-P53-CTX)

University Medical Center Groningen (UMCG)

Status and phase

Completed

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: P53-SLP vaccine

Drug: Cyclophosphamide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00844506

EUDRACT 2007-007734-19

CCMO NL21308.000.07

ISA-P53-CTX

Details and patient eligibility

About

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.

Enrollment

19 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).