Status:
COMPLETED
Targeted Radiation Therapy for Ovarian Cancer: Intraperitoneal Treatment With 211-astatine-MX35 F(ab')2
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
Swedish Cancer Society
The Swedish Research Council
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-85 years
Phase:
EARLY_PHASE1
Brief Summary
In this alpha-radioimmunotherapy study groups of 3 patients with recurring epithelial ovarian cancer treated by salvage chemo-therapy and being in complete or good partial remission will receive one i...
Detailed Description
* Five days prior to therapy the patient is provided with a central intra venous line and an abdominal catheter will be introduced during laparoscopy. To investigate the access to the whole abdominal ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 5 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04461457
Start Date
February 5 2005
End Date
January 19 2012
Last Update
July 8 2020
Active Locations (1)
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1
Sahlgrenska University Hospital, Dept of Oncology
Gothenburg, Sweden, 41345