Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
Study NCT ID:
NCT04461457
Status:
COMPLETED
Last Update Posted:
2020-07-08
First Post:
2020-06-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Targeted Radiation Therapy for Ovarian Cancer: Intraperitoneal Treatment With 211-astatine-MX35 F(ab')2
Sponsor:
Vastra Gotaland Region
Organization:
Study Overview
Official Title:
Targeted Radiation Therapy for Ovarian Cancer: Intraperitoneal Treatment With 211-astatine-MX35 F(ab')2
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: