Phase I trial of the anti-Lewis Y drug immunoconjugate BR96-doxorubicin in patients with Lewis Y-expressing epithelial tumors

Journal of Clinical Oncology

Volumn 18, Issue 11, 2000, Pages 2282-2292

  Saleh, Mansoor N ^a   Sugarman, Steve ^a   Murray, James ^a   Ostroff, Joy B ^a   Healey, Diane ^a   Jones, Dennie ^a   Daniel, Carol R ^a   LeBherz, Donna ^a   Brewer, Hannah ^a   Onetto, Nicole ^a   LoBuglio, Albert F ^a  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY CONJUGATE; ANTINEOPLASTIC AGENT; DOXORUBICIN; MONOCLONAL ANTIBODY;

ADULT; AGED; ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER IMMUNOLOGY; CLINICAL TRIAL; COLORECTAL CANCER; FEMALE; GASTRITIS; GASTROINTESTINAL ENDOSCOPY; GASTROINTESTINAL TOXICITY; HEAD AND NECK CANCER; HUMAN; LUNG CANCER; MAJOR CLINICAL STUDY; MALE; OVARY CANCER; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; STOMACH CANCER; TREATMENT OUTCOME;

EID: 0034077405     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2000.18.11.2282     Document Type: Article

References (27)

1. Hellström I, Hellström KE, Siegall CB, et al: Immunoconjugates and immunotoxins for therapy of carcinomas, in August JT, Anders MW, Murad F, Coyle JT (eds): Advances in Pharmacology. San Diego, CA, Academic Press, 1995, pp 349-388
2. Schlom J: Monoclonal antibodies in cancer therapy. Biol Ther Cancer 20:507-521, 1995
3. Pietersz GA, Krauer K: Antibody-targeted drugs for the therapy of cancer. J Drug Target 2:183-215, 1994
4. Frankel AE, Tagge EP, Willingham MC: Clinical trials of targeted toxins. Semin Cancer Biol 6:307-317, 1995
5. Larson S: Radioisotope conjugates. Biol Ther Cancer 20:534-552, 1995
6. LoBuglio AF, Saleh MN: Monoclonal antibody therapy of cancer, in Davis S (ed): Critical Reviews in Oncology/Hematology. New York, NY, Elsevier Publishers, 1992, pp 271-282
7. LoBuglio AF, Saleh NM: Monoclonal antibodies: II. Biological therapy, in Niederhuber JE (ed): Current Therapy in Oncology. St. Louis, MO, BC Decker, 1993, pp 41-49
8. Trail PA, Willner D, Hellström KE: Site-directed delivery of anthracyclines for cancer therapy. Drug Dev Res 34:196-209, 1995
9. Y-related cell surface antigen. Cancer Res 50:2183-2190, 1990
10. Trail PA, Willner D, Lasch SJ, et al: Cure of xenografted human carcinomas by BR96-doxorubicin immunoconjugates. Science 261: 212-215, 1993
11. Yamold S, Fell PH: Chimerization of antitumor antibodies via homologous recombination conversion vectors. Cancer Res 54:506-512, 1994
12. Comereski CR, Peden WM, Davidson TJ, et al: BR96-doxorubicin conjugate (BMS-182248) versus doxorubicin: A comparative toxicity assessment in rats. Toxicol Pathol 22:473-488, 1994
13. Y specific antibody with potent antitumor activity is internalized and degraded in lysosomes. Am J Pathol 142:607-622, 1993
14. Willner D, Trail PA, Hofstead SJ, et al: (6-Maleimidocaproyl) hydrazone of doxorubicin: A new derivative for the preparation of immunoconjugates of doxorubicin. Bioconjug Chem 4:521-527, 1993
15. Trail PA, Slichenmyer WJ, Birkhofer MJ, et al: BR96-doxorubicin immunoconjugate for treatment of patients with carcinoma. Proc Am Assoc Cancer Res 37:626, 1996 (abstr 3212)
16. Sjogren HO, Isaksson M, Willner D, et al: Antitumor activity of carcinoma-reactive BR96-doxorubicin conjugate against human carcinomas in athymic mice and rats and syngeneic rat carcinomas in immunocompetent rats. Cancer Res 57:4530-4536, 1997
17. Trail PA, Willner D, Lasch SJ, et al: Antigen specific activity of carcinoma reactive BR64-adriamycin conjugates evaluated in vitro and in human tumor xenograft models. Cancer Res 52:5693-5700, 1992
18. Hryniuk W, Levine MN: Analysis of dose intensity for adjuvant chemotherapy trials in stage II breast cancer. J Clin Oncol 4:1162-1170, 1986
19. Wood WC, Budman DR, Korzun AH, et al: Dose and dose intensity of adjuvant chemotherapy for stage II. node-positive breast carcinoma. N Engl J Med 330:1253-1259, 1994
20. Fetting J, Gray R, Abeloff M, et al: CAF vs a 16-week multidrug regimen as adjuvant therapy for receptor-negative, node-positive breast cancer: An intergroup study. Proc Am Soc Clin Oncol 14:96, 1992 (abstr 83)
21. Doroshow JH: Anthracyclines, in Chabner BA, Longo DL (eds): Cancer Chemotherapy and Biotherapy: Principles and Practice (ed 2). Philadelphia, PA, Lippincott-Raven, 1996, pp 409-434
22. Myers RB, Srivastava S, Grizzle WE: Lewis Y antigen as detected by the monoclonal antibody BR96 is expressed strongly in prostatic adenocarcinoma. J Urol 153:1572-1574, 1995
23. Saleh MN, LoBuglio AF, Sugarman S, et al: Gastrointestinal effects of chimeric BR96-doxorubicin conjugate. Proc Am Assoc Cancer Res 36:483, 1995 (abstr 2876)
24. Grasela D, LoBuglio AF, Saleh MN, et al: Parametric model for BR96-doxorubicin pharmacokinetics (PK) in cancer patients. Proc Am Assoc Cancer Res 36:234, 1995 (abstr 1393)
25. Y antigen. Proc Am Soc Clin Oncol 14:472, 1995 (abstr 1532)
26. Y positive metastatic cancer. Antibody Immunoconjug Radiopharm 8:61, 1995 (abstr 15)
27. Trail P, Onetto N, Lasch S, et al: Tumor penetration and functional activity of BMS-182248 following administration in a phase I clinical trial. Proc Am Assoc Cancer Res 36:499, 1995 (abstr 2974)