Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Medical Center Groningen
With
ISA Pharmaceuticals B.V.
Dutch Cancer Society
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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:
\- Adequate venous access for blood collection and i.v. administration of cyclophosphamide.
You may not be if
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).
