Phase I radioimmunotherapy trial with iodine-131-CC49 in metastatic colon carcinoma Journal Article
| Authors: | Divgi, C. R.; Scott, A. M.; Dantis, L.; Capitelli, P.; Siler, K.; Hilton, S.; Finn, R. D.; Kemeny, N.; Kelsen, D.; Kostakoglu, L.; Schlom, J.; Larson, S. M. |
| Article Title: | Phase I radioimmunotherapy trial with iodine-131-CC49 in metastatic colon carcinoma |
| Abstract: | CC49 is a murine monoclonal antibody (MAb) that reacts against the TAG-72 antigen. We carried out a Phase I study with escalating doses of 131I- CC49 in patients with advanced colorectal cancer expressing the TAG-72 antigen to determine the dose-limiting toxicity and therapeutic efficacy, if any, of the radioimmunoconjugate. Methods: Twenty-four patients with TAG-72- expressing colorectal cancer were treated with escalating doses of 131I- CC49 starting at 15 mCi/m2 and going up to 90 mCi/m2 of 131I labeled to 20 mg MAb CC49. Patients were selected if TAG-72 was expressed in ≥50% of cells in previously resected tumor and at least one metastasis was demonstrable on standard imaging such as CT. All patients had failed conventional chemotherapy and had not received prior radiotherapy or murine MAb. Patients were under radiation isolation precautions until whole-body radioactivity decreased to ≤5 mR/hr at 1 m. Whole-body scintigrams were obtained prior to discharge and 1 and 2 wk after infusion in all patients. SPECT imaging was carried out at least once in ell patients. Results: All patients had excellent targeting of radioactivity to known tumor sites. There was no nonhematologic toxicity. Hematologic toxicity was more pronounced in those patients who had received extensive prior chemotherapy. There were no major responses. All patients developed an immune response (HAMA) within 4 wk of therapy. Conclusion: Radioimmunotherapy with 131I-CC49 is safe and there is significant therapeutic efficacy in this Phase I trial at the doses studied. There is excellent targeting of radioactivity to antigen-positive tumors. Dose-limiting toxicity is hematopoietic, with the maximum tolerated dose in this group of heavily pretreated patients being 75 mCi/m2. |
| Keywords: | adult; cancer chemotherapy; clinical article; aged; dose response; liver neoplasms; adenocarcinoma; antigen expression; metastasis; image analysis; lung neoplasms; tumor markers, biological; dose-response relationship, radiation; colorectal carcinoma; colorectal neoplasms; patient care; statistical analysis; immune response; antigens, neoplasm; iodine 131; iodine radioisotopes; radioactivity; colon carcinoma; radioimmunotherapy; glycoproteins; middle age; abdominal neoplasms; hematopoietic toxicity; human; male; female; priority journal; article; support, u.s. gov't, p.h.s.; iodine-131-cc49 |
| Journal Title: | Journal of Nuclear Medicine |
| Volume: | 36 |
| Issue: | 4 |
| ISSN: | 0161-5505 |
| Publisher: | Society of Nuclear Medicine |
| Date Published: | 1995-04-01 |
| Start Page: | 586 |
| End Page: | 592 |
| Language: | English |
| PUBMED: | 7699446 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 28 August 2018 -- Source: Scopus |
