Pretargeted radioimmunotherapy (RIT) with a novel anti-TAG-72 fusion protein
Pretargeted radioimmunotherapy (RIT) increases the dose of radionuclide delivered to tumor sites while limiting radiation to normal tissues. The three components in Pretarget include a streptavidin-containing targeting molecule, a synthetic clearing agent (sCA), and (90)Y and/or (111)In-DOTA-biotin....
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Published in | Cancer biotherapy & radiopharmaceuticals Vol. 20; no. 4; pp. 379 - 390 |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | English |
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Mary Ann Liebert, Inc
01.08.2005
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Abstract | Pretargeted radioimmunotherapy (RIT) increases the dose of radionuclide delivered to tumor sites while limiting radiation to normal tissues. The three components in Pretarget include a streptavidin-containing targeting molecule, a synthetic clearing agent (sCA), and (90)Y and/or (111)In-DOTA-biotin. This trial determined the feasibility and safety of using a genetically engineered fusion protein directed to TAG-72 as the targeting agent. Nine (9) patients with metastatic colorectal cancer (TAG-72+) received 160 mg/m(2) of CC49Fusion protein intravenously (i.v.), followed by the sCA, 45 mg/m(2) i.v. Twenty-four (24) hours later, patients received radiolabeled DOTA-biotin (either 0.65 or 1.3 mg/m(2)). All patients received 5 mCi of (111)In-DOTA-biotin for imaging and dosimetry purposes and patients 4-9 received 10 mCi/m2 of (90)Y-DOTA-biotin as well. The mean plasma T1/2 of CC49Fusion protein was 23 +/- 6 hours. Greater than 95% of the circulating CC49Fusion protein was eliminated from the circulation within 6 hours of sCA administration. The radiolabeled DOTA-biotin rapidly localized to tumor sites while the unbound fraction was rapidly excreted. The mean tumor-to-marrow radiation dose ratio was 139:1 and mean tumor: whole body was 56:1. No infusion-related, renal, hepatic, or hematologic toxicities were noted. CC49Fusion protein performs well in a pretargeted RIT schema, and further study with escalating doses of (90)Y should be pursued. This strategy has the potential to deliver effective radiation tumor doses to TAG- 72+ tumors. |
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AbstractList | Pretargeted radioimmunotherapy (RIT) increases the dose of radionuclide delivered to tumor sites while limiting radiation to normal tissues. The three components in Pretarget include a streptavidin-containing targeting molecule, a synthetic clearing agent (sCA), and (90)Y and/or (111)In-DOTA-biotin. This trial determined the feasibility and safety of using a genetically engineered fusion protein directed to TAG-72 as the targeting agent. Nine (9) patients with metastatic colorectal cancer (TAG-72+) received 160 mg/m(2) of CC49Fusion protein intravenously (i.v.), followed by the sCA, 45 mg/m(2) i.v. Twenty-four (24) hours later, patients received radiolabeled DOTA-biotin (either 0.65 or 1.3 mg/m(2)). All patients received 5 mCi of (111)In-DOTA-biotin for imaging and dosimetry purposes and patients 4-9 received 10 mCi/m2 of (90)Y-DOTA-biotin as well. The mean plasma T1/2 of CC49Fusion protein was 23 +/- 6 hours. Greater than 95% of the circulating CC49Fusion protein was eliminated from the circulation within 6 hours of sCA administration. The radiolabeled DOTA-biotin rapidly localized to tumor sites while the unbound fraction was rapidly excreted. The mean tumor-to-marrow radiation dose ratio was 139:1 and mean tumor: whole body was 56:1. No infusion-related, renal, hepatic, or hematologic toxicities were noted. CC49Fusion protein performs well in a pretargeted RIT schema, and further study with escalating doses of (90)Y should be pursued. This strategy has the potential to deliver effective radiation tumor doses to TAG- 72+ tumors. Pretargeted radioimmunotherapy (RIT) increases the dose of radionuclide delivered to tumor sites while limiting radiation to normal tissues. The three components in Pretarget registered include a streptavidin-containing targeting molecule, a synthetic clearing agent (sCA), and super(90)Y and/or super(111)In-DOTA-biotin. This trial determined the feasibility and safety of using a genetically engineered fusion protein directed to TAG-72 as the targeting agent. Nine (9) patients with metastatic colorectal cancer (TAG-72+) received 160 mg/m super(2) of CC49 Fusion protein intravenously (i.v.), followed by the sCA, 45 mg/m super(2) i.v. Twenty-four (24) hours later, patients received radiolabeled DOTA-biotin (either 0.65 or 1.3 mg/m super(2)). All patients received 5 mCi of super(111)In-DOTA-biotin for imaging and dosimetry purposes and patients 4-9 received 10 mCi/m super(2) of super(90)Y-DOTA-biotin as well. The mean plasma T one half of CC49 Fusion protein was 23 plus or minus 6 hours. Greater than 95% of the circulating CC49 Fusion protein was eliminated from the circulation within 6 hours of sCA administration. The radiolabeled DOTA-biotin rapidly localized to tumor sites while the unbound fraction was rapidly excreted. The mean tumor-to-marrow radiation dose ratio was 139:1 and mean tumor:whole body was 56:1. No infusion-related, renal, hepatic, or hematologic toxicities were noted. CC49 Fusion protein performs well in a pretargeted RIT schema, and further study with escalating doses of super(90)Y should be pursued. This strategy has the potential to deliver effective radiation tumor doses to TAG-72+ tumors. |
Author | Khazaeli, M B Sims, Robert B Shen, Sui Chen, Kuang-Ho LoBuglio, Albert F Breitz, Hazel Besh, Stephen Axworthy, Don B Meredith, Ruby F Forero-Torres, Andres Percent, Ivor |
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BackLink | https://www.ncbi.nlm.nih.gov/pubmed/16114986$$D View this record in MEDLINE/PubMed |
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SubjectTerms | Adenocarcinoma - therapy Aged Antigens, Neoplasm - therapeutic use Biotin - analogs & derivatives Biotin - chemistry Biotin - pharmacology Clinical Trials as Topic Cohort Studies Enzyme-Linked Immunosorbent Assay Female Gamma Cameras Gastrointestinal Neoplasms - therapy Glycoproteins - therapeutic use Humans Indium Radioisotopes Liver Neoplasms - secondary Male Middle Aged Neoplasm Metastasis Organometallic Compounds - pharmacology Radioimmunotherapy - methods Radioisotopes Radiometry Radiopharmaceuticals - therapeutic use Recombinant Fusion Proteins - chemistry Rhenium Streptavidin - pharmacology Time Factors Treatment Outcome Yttrium Radioisotopes - therapeutic use |
Title | Pretargeted radioimmunotherapy (RIT) with a novel anti-TAG-72 fusion protein |
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