drugset / Trial / NCT04461457
Targeted Radiation Therapy for Ovarian Cancer: Intraperitoneal Treatment With 211-astatine-MX35 F(ab')2
Phase 0
Completed
12 enrolled
Vastra Gotaland Region
Sahlgrenska University Hospital · collabSwedish Cancer Society · collabThe Swedish Research Council · collab
SequentialOpen-labelTreatment
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).
Timeline
- Start
- 2005-02-05
- Primary completion
- 2011-03-19
- Completion
- 2012-01-19
Publications
- Results Andersson H, Cederkrantz E, Back T, Divgi C, Elgqvist J, Himmelman J, Horvath G, Jacobsson L, Jensen H, Lindegren S, Palm S, Hultborn R. Intraperitoneal alpha-particle radioimmunotherapy of ovarian cancer patients: pharmacokinetics and dosimetry of (211)At-MX35 F(ab')2--a phase I study. J Nucl Med. 2009 Jul;50(7):1153-60. doi: 10.2967/jnumed.109.062604. Epub 2009 Jun 12.
- Results Cederkrantz E, Andersson H, Bernhardt P, Back T, Hultborn R, Jacobsson L, Jensen H, Lindegren S, Ljungberg M, Magnander T, Palm S, Albertsson P. Absorbed Doses and Risk Estimates of (211)At-MX35 F(ab')2 in Intraperitoneal Therapy of Ovarian Cancer Patients. Int J Radiat Oncol Biol Phys. 2015 Nov 1;93(3):569-76. doi: 10.1016/j.ijrobp.2015.07.005. Epub 2015 Jul 11.
- Results Hallqvist A, Bergmark K, Back T, Andersson H, Dahm-Kahler P, Johansson M, Lindegren S, Jensen H, Jacobsson L, Hultborn R, Palm S, Albertsson P. Intraperitoneal alpha-Emitting Radioimmunotherapy with 211At in Relapsed Ovarian Cancer: Long-Term Follow-up with Individual Absorbed Dose Estimations. J Nucl Med. 2019 Aug;60(8):1073-1079. doi: 10.2967/jnumed.118.220384. Epub 2019 Jan 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 211-astatine MX35 F(ab')2 | Monoclonal antibody | 50 unknown | Other |
| Subject | 211-astatine MX35 F(ab')2 | Monoclonal antibody | 100 unknown | Other |
| Subject | 211-astatine MX35 F(ab')2 | Monoclonal antibody | 200 unknown | Other |
| Subject | 211-astatine MX35 F(ab')2 | Monoclonal antibody | 300 unknown | Other |