NCT04461457

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 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).

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 cavity and possible catheter leakage, a 99mTc-colloid, will be infused intra peritoneally (IP) within 1.0 L of a gluco-polymer (Extraneal®). * At the day of treatment vital signs will be measured prior to and after the 30 min infusion and at least every second hour during the first 6 hours after infusion, daily for the remainder of the in-hospital stay and at a minimum at 2, 3, 4 and 8 weeks after the IP infusion. Blood samples will be obtained for pharmacokinetic analyses every hour after completion of the IP infusion for 8 hours, then every 6 hours, together with sampling from the i.p. catheter. * SPECT imaging of the whole abdominal cavity and thorax including the thyroid may be performed following completion of the IP infusion and at approx 8 or 20hrs post infusion. * Physical examination and electrocardiogram will be done prior to and 4 weeks after the IP infusion. Clinical biochemical and hematological parameters will be monitored weekly after treatment. Blood samples to evaluate immunogenicity as well as cancer antigen-125 (CA-125) will also be taken at 2 and 8 weeks after treatment. * The first patient will be observed for at least 4 weeks with any observed toxicity is Grade 2 or less, before the additional patient is accrued at the dose level. * Dosimetry safety criteria: Based upon published data on maximal tolerated absorbed dose (Gy) recalculated to equivalent dose (Sv) with the assumption that the relative biological effectiveness (RBE) = 5, a limit for organ doses is defined. If any organ would reach the defined limit the study will be stopped.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	211-astatine MX35 F(ab')2	Alpha emitting radionuclide 211At conjugated to monoclonal antibody MX35 F(ab')2. Targeting the sodium phosphate transporter (NaPi2b).

Timeline

• Start date: 2005-02-05
• Primary completion: 2011-03-19
• Completion: 2012-01-19
• First posted: 2020-07-08
• Last updated: 2020-07-08

Locations

1 site across 1 country: Sweden