Targeted Radiation Therapy for Ovarian Cancer: Intraperitoneal Treatment With 211-astatine-MX35 F(ab')2
Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically confirmed ovarian or tubal or primary peritoneal adenocarcinoma.
- Patients must have a recurrent intraperitoneal cancer and treated by a salvage chemotherapy to complete or good partial remission
The following laboratory and clinical results within 2 weeks prior to first study day:
Absolute neutrophil count (ANC) > 1.5 x 109/L Platelet count > 100 x 109/L Serum bilirubin < upper limit of normal(ULN) Aspartate aminotransaminase (ASAT) < 1.5 x ULN Serum aminotransferase (ALAT) < 1.5 x ULN Serum creatinine < 1.5 x upper limit of normal Thyreoglobulin baseline information Thyroid-stimulating hormone (TSH) baseline information T4 baseline information
- Karnofsky performance status > 70.
- Must understand written and spoken Swedish
- Before any trial-specific procedures or treatment can be performed, the patient must give written informed consent for participation in the trial.
Exclusion Criteria:
- Active parenchymal disease (distant metastasis) (i.e. stage IV International Federation of Gynecology and Obstetrics (FIGO) classification.
- Presence of diagnosed extra abdominal metastasis
- Clinically significant heart disease.
- Electrocardiographic demonstrating clinically significant arrhythmias.
- Other serious illnesses, e.g. serious infections requiring antibiotics, coagulation disorders.
- Chronic inflammatory bowel disease.
- Chemotherapy, biologic therapy, or immunotherapy within 4 weeks prior
- Advanced abdominal adherences.
Sites / Locations
- Sahlgrenska University Hospital, Dept of Oncology
Arms of the Study
Arm 1
Experimental
Intraperitoneal Radioimmunotherapy boost
Four groups of 3 patients with recurring ovarian cancer treated by salvage chemo-therapy and being in complete or good partial remission will receive one IP dose of 211astatine-MX35 F(ab'2). Starting at 50 MBq/L. Dose escalation 100 Mbq/L, 200 MBq/L and finally 300 MBq/L.