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

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).

Sex

Female

Minimum age

18 Years

Maximum age

85 Years

Inclusion Criteria:

1. Patients must have histologically confirmed ovarian or tubal or primary peritoneal adenocarcinoma.
2. Patients must have a recurrent intraperitoneal cancer and treated by a salvage chemotherapy to complete or good partial remission
3. 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
4. Karnofsky performance status \> 70.
5. Must understand written and spoken Swedish
6. Before any trial-specific procedures or treatment can be performed, the patient must give written informed consent for participation in the trial.

Exclusion Criteria:

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

• RESULTAndersson 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. PMID 19525452
• RESULTCederkrantz 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. PMID 26460999
• RESULTHallqvist 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. PMID 30683761