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

NCT04461457 | Completed Early Phase 1

• 3 other identifiers: 001-211Astatine151:2004/26262S571-03
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (3)

• Maximum observed concentration (Cmax) of Astatine 211

  Decay corrected activity concentration in serum, intraperitoneal fluid and urine.

  Sampled from +1 hour to +48 hrs post infusion.

• Area under the curve (AUC) of astatine 211 from time of dosing to 48 hrs after dosing

  Decay corrected activity concentration in serum, intraperitoneal fluid and urine, including actual imaging quantification on gamma-Camera scintigraphy.

  Sampled from +1 hour to +48 hrs post infusion.

• Toxicity: hematology, liver, kidney, thyroid function

  As defined by NCI Common Toxicity Criteria v2.0

  From procedure start (implantation of catheter) to 8 weeks after infusion

Study Arms (1)

Intraperitoneal Radioimmunotherapy boost

EXPERIMENTAL

Four groups of 3 patients with recurring ovarian cancer treated by salvage chemo-therapy and being in complete or good partial remission will receive one IP dose of 211astatine-MX35 F(ab'2). Starting at 50 MBq/L. Dose escalation 100 Mbq/L, 200 MBq/L and finally 300 MBq/L.

Combination Product: 211-astatine MX35 F(ab')2

Interventions

211-astatine MX35 F(ab')2 COMBINATION_PRODUCT

Alpha emitting radionuclide 211At conjugated to monoclonal antibody MX35 F(ab')2. Targeting the sodium phosphate transporter (NaPi2b).

Intraperitoneal Radioimmunotherapy boost

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Karnofsky performance status \> 70.
• Must understand written and spoken Swedish
• Before any trial-specific procedures or treatment can be performed, the patient must give written informed consent for participation in the trial.

You may not qualify if:

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Swedish Cancer Society: collaborator
• The Swedish Research Council: collaborator
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Sahlgrenska University Hospital, Dept of Oncology

Gothenburg, 41345, Sweden

Location

Related Publications (3)

• 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.

  PMID: 19525452 RESULT

• 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.

  PMID: 26460999 RESULT

• 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.

  PMID: 30683761 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: early phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: To investigate the pharmacokinetics of the conjugate 211At-MX35 F(ab') 2. Groups of 3 patients will be treated at increasing activity concentrations starting at 50 MBq/L

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 8, 2020
• Study Start: February 5, 2005
• Primary Completion: March 19, 2011
• Study Completion: January 19, 2012
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)