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This research is being conducted to determine the biodistribution of radiolabeled amatuximab in tumor and non-tumor tissues in subjects with mesothelin over expressing cancer including mesothelioma, pancreatic, ovarian or non small cell lung cancer.
The primary objective is to determine the biodistribution of radiolabeled amatuximab in tumor and nontumor tissues in subjects with mesothelin over-expressing cancers including mesothelioma, pancreatic, ovarian, and non small cell lung cancer. This is a single-center, single-dose, open-label, pilot study of amatuximab in approximately 20 subjects with mesothelin expressing tumors. 111Indium-radiolabeled amatuximab (5 mCi) will be administered. Serial SPECT imaging (at 3 specific time points up to 196 hours after cold infusion) will be performed to determine binding to tumor and nontumor tissue. Subjects will be observed closely for safety and possible development of anti-amatuximab antibodies. Pharmacokinetics of radiolabeled antibody will be determined with imaging over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amatuximab infusion | Experimental | Subjects will receive one infusion of radiolabeled amatuximab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amatuximab | Drug | Subjects will receive one infusion of radiolabeled amatuximab. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective: determine biodistribution of radiolabeled amatuximab in tumor and nontumor tissue | To determine the biodistribution of radiolabeled amatuximab in tumor and nontumor tissue in subjects with mesothelin over expressing cancer including mesothelioma, pancreatic, ovarian or nonsmall cell lung cancer by performing SPECT imaging to determine binding to tumor and non-tumor tissue. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary objectives: determine the safety of a single IV of Indium-CHX-A amatuximab | To determine the safety of a single IV of Indium-CHX-A amatuximab by collecting safety data during/ after the infusions as well as obtain any potential drug-related AEs 30 days post infusion | 1 year |
| Pharmacokinetic and serum levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raffit Hassan, MD | National Institutes of Health (NIH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cacner Institue | Bethesda | Maryland | 20892' | United States |
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| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D010190 | Pancreatic Neoplasms |
| D010051 | Ovarian Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C526187 | amatuximab |
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To determine the PK parameters of the Indium-CHX-A amatuximab with imaging, and serum levels collected over time |
| 1 year |
| uptake of Indium-CHX-A amatuximab | To explore the uptake of Indium-CHX-A amatuximab with mesothelin tumor expression as determined by ICH | 1 year |
| occurrence of HACA | To tabulate the occurrence of HACA which will be measured through serum samples collected over time | 1 year |
| correlate shed serum mesothelin to imaging | To correlate shed serum mesothelin to imaging obtained after antibody administration. | 1 year |
| D018301 |
| Neoplasms, Mesothelial |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010049 | Ovarian Diseases |
| 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 |
| D006058 | Gonadal Disorders |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |