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| ID | Type | Description | Link |
|---|---|---|---|
| 151:2004/26262 | Other Identifier | Swedish Medical Products Agency (MPA) | |
| S571-03 | Other Identifier | Ethics committee, Sahlgrenska Academy, Göteborg University |
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| Name | Class |
|---|---|
| Swedish Cancer Society | OTHER |
| The Swedish Research Council | OTHER_GOV |
| Sahlgrenska University Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital, Dept of Oncology | Gothenburg | 41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19525452 | Result | 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. | |
| 26460999 |
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Upun specific request, data could be considered to be shared.
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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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
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| 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. |
| 30683761 | 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. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |