TheranosticTrials.org

Clinical Trial · NCT04461457

Targeted Radiation Therapy for Ovarian Cancer: Intraperitoneal Treatment With 211-astatine-MX35 F(ab')2

Overview

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 intra peritoneal infusion of 211 astatine (211At)-MX35 F(ab')2 . Patients will receive a single dose of MX35 F(ab')2 radiolabeled with increasing activity concentration of 211At in 1.0 - 2 L Extraneal® solution starting at an activity concentration of 50 megabecquerel per litre (MBq/L).

Sponsor

Unknown Organization

Phase

Early Phase 1

ClinicalTrials.gov

NCT04461457

Drug / Compound

colloid

Isotope(s):
Target(s):
  • No Explicit Target

MX35 F(ab')2

Isotope(s):
Target(s):
  • No Explicit Target
Ligand Class: Small Proteins and Antibody Fragments

Eligibility

Inclusion

  • Karnofsky performance status \> 70.
  • 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
  • Must understand written and spoken Swedish

Exclusion

  • Advanced abdominal adherences.
  • Other serious illnesses, e.g. serious infections requiring antibiotics, coagulation disorders.
  • Presence of diagnosed extra abdominal metastasis
  • Clinically significant heart disease.
  • Chronic inflammatory bowel disease.
  • Chemotherapy, biologic therapy, or immunotherapy within 4 weeks prior
  • Electrocardiographic demonstrating clinically significant arrhythmias.
  • Active parenchymal disease (distant metastasis) (i.e. stage IV International Federation of Gynecology and Obstetrics (FIGO) classification.