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Clinical Trials |
Stanford University School of Medicine, Department of Radiation Oncology [S. J. K.], and Department of Diagnostic Radiology, Division of Nuclear Medicine [M. L. G.], Stanford, California 94305; University of Nebraska Medical Center, UNMC/Eppley Cancer Center [M. T., D. C.], Omaha, Nebraska 68198; Virginia Mason Medical Center, Medical Oncology, Seattle, Washington 98101 [P. L. W., H. B.]; Janssen Research Foundation, Titusville, New Jersey 08560 [L. G., I. D. H.]; Fox Chase Cancer Center, Department of Medical Oncology, Philadelphia, Pennsylvania 19111 [G. P. A., L. M. W.]; NeoRx Corporation, Seattle, Washington 98119 [D. A., S. G., K. B.]; and Pacific Northwest National Laboratory, Richland, Washington 99352 [D. R. F.]
A
Phase II study of yttrium-90-tetra-azacyclododecanetetra-acetic
acid-biotin (90Y-DOTA-biotin) pretargeted by NR-LU-10
antibody/streptavidin (SA) was performed. The primary objectives of the
study were to evaluate the efficacy and safety of this therapy in
patients with metastatic colon cancer. Twenty-five patients were
treated with a single dose of 110 mCi/m2 (mean administered
dose, 106.5 ± 10.3 mCi/m2) of
90Y-DOTA-biotin. There were three components of the
therapy. Patients first received NR-LU-10/SA on day 1. A clearing agent
(biotin-galactose-human serum albumin) was administered 
48 h after
the NR-LU-10/SA to remove residual circulating unbound NR-LU-10/SA.
Lastly, 24 h after administration of clearing agent, patients
received biotin-DOTA-labeled with 110 mCi/m2
90Y. All three components of the therapy were administered
i.v. Both hematological and nonhematological toxicities were observed.
Diarrhea was the most frequent grade 4 nonhematological toxicity (16%;
with 16% grade 3 diarrhea). Hematological toxicity was less severe
with 8% grade 3 and 8% grade 4 neutropenia and 8% grade 3 and 16%
grade 4 thrombocytopenia. The overall response rate was 8%. Two
partial responders had freedom from progression of 16 weeks. Four
patients (16%) had stable disease with freedom from progression of
10–20 weeks. Despite the relatively disappointing results of this
study in terms of therapeutic efficacy and toxicity, proof of principle
was obtained for the pretargeting approach. In addition, valuable new
information was obtained about normal tissue tolerance to low-dose-rate
irradiation that will help to provide useful guidelines for future
study designs.
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M. Zhang, Z. Yao, K. Garmestani, D. B. Axworthy, Z. Zhang, R. W. Mallett, L. J. Theodore, C. K. Goldman, M. W. Brechbiel, J. A. Carrasquillo, et al. Pretargeting radioimmunotherapy of a murine model of adult T-cell leukemia with the alpha -emitting radionuclide, bismuth 213 Blood, June 17, 2002; 100(1): 208 - 216. [Abstract] [Full Text] [PDF]
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D. M. Goldenberg Targeted Therapy of Cancer with Radiolabeled Antibodies J. Nucl. Med., May 1, 2002; 43(5): 693 - 713. [Abstract] [Full Text] [PDF]
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 C.-H. Chang, R. M. Sharkey, E. A. Rossi, H. Karacay, W. McBride, H. J. Hansen, J.-F. Chatal, J. Barbet, and D. M. Goldenberg Molecular Advances in Pretargeting Radioimunotherapy with Bispecific Antibodies Mol. Cancer Ther., May 1, 2002; 1(7): 553 - 563. [Abstract] [Full Text] [PDF]
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G. Liu, K. Mang'era, N. Liu, S. Gupta, M. Rusckowski, and D. J. Hnatowich Tumor Pretargeting in Mice Using 99mTc-Labeled Morpholino, a DNA Analog J. Nucl. Med., March 1, 2002; 43(3): 384 - 391. [Abstract] [Full Text] [PDF]
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O. W. Press, M. Corcoran, K. Subbiah, D. K. Hamlin, D. S. Wilbur, T. Johnson, L. Theodore, E. Yau, R. Mallett, D. L. Meyer, et al. A comparative evaluation of conventional and pretargeted radioimmunotherapy of CD20-expressing lymphoma xenografts Blood, October 15, 2001; 98(8): 2535 - 2543. [Abstract] [Full Text] [PDF]
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O. C. Boerman, J. van Eerd, W. J.G. Oyen, and F. H.M. Corstens A 3-Step Pretargeting Strategy to Image Infection J. Nucl. Med., September 1, 2001; 42(9): 1405 - 1411. [Abstract] [Full Text] [PDF]
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 D. L. Meyer, J. Schultz, Y. Lin, A. Henry, J. Sanderson, J. M. Jackson, S. Goshorn, A. R. Rees, and S. S. Graves Reduced antibody response to streptavidin through site-directed mutagenesis Protein Sci., March 1, 2001; 10(3): 491 - 503. [Abstract] [Full Text]
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J. Schultz, Y. Lin, J. Sanderson, Y. Zuo, D. Stone, R. Mallett, S. Wilbert, and D. Axworthy A Tetravalent Single-chain Antibody-Streptavidin Fusion Protein for Pretargeted Lymphoma Therapy Cancer Res., December 1, 2000; 60(23): 6663 - 6669. [Abstract] [Full Text]
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M. Tempero, P. Leichner, J. Baranowska-Kortylewicz, K. Harrison, S. Augustine, J. Schlom, J. Anderson, J. Wisecarver, and D. Colcher High-Dose Therapy with 90Yttrium-labeled Monoclonal Antibody CC49: A Phase I Trial Clin. Cancer Res., August 1, 2000; 6(8): 3095 - 3102. [Abstract] [Full Text]
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