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6. Targeting Lewis Y (LeY) in small cell lung cancer (SCLC) with a humanized monoclonal antibody, hu3S193: A pilot trial testing two dose levels

Author

Krug LM, Milton D, Jungbluth AA, Chen LC, Pandit Taskar N, Nagel A, Jones J, Kris MG, Finn R, Smith Jones P, Oettgen H, Scott AM, Old L, Divgi C., QUAIA, Emilio, Krug, Lm, Milton, D, Jungbluth, Aa, Chen, Lc, Quaia, Emilio, Pandit Taskar, N, Nagel, A, Jones, J, Kris, Mg, Finn, R, Smith Jones, P, Oettgen, H, Scott, Am, Old, L, and Divgi, C.

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Pathology, Lung Neoplasms, Time Factors, medicine.drug_class, medicine.medical_treatment, Bone Neoplasms, Pilot Projects, Antibodies, Monoclonal, Humanized, Monoclonal antibody, Gastroenterology, Immunoglobulin G, lung, Lewis Blood Group Antigens, Monoclonal Antibody Hu3S193, Internal medicine, medicine, Humans, cancer, Tissue Distribution, Carcinoma, Small Cell, Aged, Chemotherapy, biology, Brain Neoplasms, business.industry, Indium Radioisotopes, Liver Neoplasms, Antibodies, Monoclonal, Middle Aged, Radioimmunotherapy, SPECT, Treatment Outcome, Oncology, Monoclonal, biology.protein, Immunohistochemistry, Female, Antibody, business, lung, cancer, SPECT
Abstract

Introduction Lewis Y (Le y ) is a blood group antigen with robust expression on the surface of epithelial tumors, including small cell lung cancer (SCLC), making it a potential target for antibody-based immunotherapy. 3S193, an immunoglobulin G 3 monoclonal antibody, has demonstrated superior specificity, affinity, and cytotoxicity over other anti-Le y antibodies. A phase I trial of humanized 3S193 (hu3S193) with dosing up to 40 mg/m 2 demonstrated tumor targeting without serious toxicities or the development of human anti-human antibodies. Methods We tested the targeting and pharmacokinetics of hu3S193 in patients with SCLC. Eligibility required progressive SCLC treated with up to three previous chemotherapy regimens, measurable disease not previously irradiated, and tumor samples positive for 3S193 by immunohistochemistry. Patients received four weekly injections of hu3S193, five patients at 10 mg/m 2 and five patients at 20 mg/m 2 . The first and fourth injections were radiolabeled with indium-111 for gamma camera imaging. Results Of 40 patients screened, 25 of 34 (74%) assessable SCLC tumor samples were 3S193 positive by immunohistochemistry. Ten patients were treated with hu3S193; nine completed all four injections. All fluorodeoxyglucose (FDG)-avid lesions >2 cm were visualized on antibody single-photon emission computed tomography. Some lesions overlying vascular structures could not be visualized. No difference was noted in imaging or pharmacokinetics between the first and fourth injections. Toxicities included grade 2 urticaria ( n = 1), grade 1 vomiting ( n = 2), and grade 2 hypertension ( n = 1) transiently after infusion at the higher dose. Conclusions Given the strong tumor targeting, particularly at the higher dose, the favorable toxicity profile, and the potential for immunomodulatory effects, hu3S193 warrants further investigation in SCLC.

Published
2007

12. Targeted therapy of renal cell carcinoma: synergistic activity of cG250-TNF and IFNg.

Author

Bauer, S., Oosterwijk-Wakka, J.C., Adrian, N., Oosterwijk, E., Fischer, E., Wuest, T., Stenner, F., Perani, A., Cohen, L., Knuth, A., Divgi, C., Jager, D., Scott, A.M., Ritter, G., Old, L.J., Renner, C., Bauer, S., Oosterwijk-Wakka, J.C., Adrian, N., Oosterwijk, E., Fischer, E., Wuest, T., Stenner, F., Perani, A., Cohen, L., Knuth, A., Divgi, C., Jager, D., Scott, A.M., Ritter, G., Old, L.J., and Renner, C.

Abstract

Contains fulltext : 81404.pdf (publisher's version ) (Closed access), Immunotherapeutic targeting of G250/Carbonic anhydrase IX (CA-IX) represents a promising strategy for treatment of renal cell carcinoma (RCC). The well characterized human-mouse chimeric G250 (cG250) antibody has been shown in human studies to specifically enrich in CA-IX positive tumors and was chosen as a carrier for site specific delivery of TNF in form of our IgG-TNF-fusion protein (cG250-TNF) to RCC xenografts. Genetically engineered TNF constructs were designed as CH2/CH3 truncated cG250-TNF fusion proteins and eucariotic expression was optimized under serum-free conditions. In-vitro characterization of cG250-TNF comprised biochemical analysis and bioactivity assays, alone and in combination with Interferon-gamma (IFNgamma). Biodistribution data on radiolabeled [(125)J] cG250-TNF and antitumor activity of cG250-TNF, alone and in combination with IFNgamma, were measured on RCC xenografts in BALB/c nu/nu mice. Combined administration of cG250-TNF and IFNgamma caused synergistic biological effects that represent key mechanisms displaying antitumor responses. Biodistribution studies demonstrated specific accumulation and retention of cG250-TNF at CA-IX-positive RCC resulting in growth inhibition of RCC and improved progression free survival and overall survival. Antitumor activity induced by targeted TNF-based constructs could be enhanced by coadministration of low doses of nontargeted IFNgamma without significant increase in side effects. Administration of cG250-TNF and IFNgamma resulted in significant synergistic tumoricidal activity. Considering the poor outcome of renal cancer patients with advanced disease, cG250-TNF-based immunotherapeutic approaches warrant clinical evaluation.

Published
2009

13. Phase II/pharmacodynamic trial of PD0332991 in patients with breast, colon, germ cell, and epithelial tumors containing amplification of CCND1.

Author

Perini, R. F., primary, DeMichele, A., additional, Vaughn, D. J., additional, Gallagher, M., additional, Sun, W., additional, Giantonio, B. J., additional, Teitelbaum, U. R., additional, Randolph, S., additional, Christensen, J. G., additional, Courtney, R. D., additional, Pryma, D. A., additional, Divgi, C. R., additional, and O'Dwyer, P. J., additional

Published
2011
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14. Imaging with [18f]-fluorodeoxyglucose positron emission tomography (FDG-PET) and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) as markers of drug effect in a phase I dose-escalation study of combined RAD 001 and cetuximab.

Author

Martin, C. A., primary, Perini, R. F., additional, Avadhani, A. N., additional, Redlinger, M., additional, Harlacker, K., additional, Flaherty, K. T., additional, Rosen, M. A., additional, Divgi, C. R., additional, and O'Dwyer, P. J., additional

Published
2011
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23. Phase 2 trial of 177Lutetium (177Lu) radiolabeled anti-prostate-specific membrane antigen (PSMA) monoclonal antibody (mAb) J591 (177Lu-J591) in patients (pts) with metastatic androgen-independent prostate cancer (AIPC)

Author

Morris, M. J., primary, Milowsky, M. I., additional, Pandit-Taskar, N., additional, Divgi, C., additional, David, K. A., additional, Rozario, C. P., additional, Vallabhajosula, S., additional, Goldsmith, S. J., additional, Scher, H. I., additional, and Nanus, D. M., additional

Published
2006
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27. 131I-LABELED M195 FOR MYELOID LEUKEMIAS

Author

Jurcic, J. G., primary, Caron, I. C., additional, Papadopoulos, E. B., additional, Mackinnon, S., additional, Divgi, C. R., additional, Finn, R. D., additional, Sgouros, G., additional, Larson, S. M., additional, Miller, W. H., additional, Yao, T. J., additional, Warrell, R. P., additional, OʼReilly, R. J., additional, and Scheinberg, D. A., additional

Published
1994
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42. Prostate cancer with leg pain

Author

Massimo Imbriaco, Yeung, H., Narajanan, G., Divgi, C., Imbriaco, Massimo, Yeung, H, Narajanan, G, and Divgi, C.

Subjects
Diagnosis, Differential, Male, Tibia, Fibula, Humans, Prostatic Neoplasms, Bone Neoplasms, Femur, Alkaline Phosphatase, Osteitis Deformans, Radionuclide Imaging, Aged

47. 131I-LABELED M195 FOR MYELOID LEUKEMIAS.

Author

Jurcic, J. G., Caron, P. C., Papadopoulos, E. B., Mackinnon, S., Divgi, C. R., Finn, R. D., Sgouros, G., Larson, S. M., Miller Jr., W. H., Yao, T. J., Warrell Jr., R. P., O'Reilly, R. J., and Scheinberg, D. A.

Published
1994
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