A Phase I trial of escalating doses of trastuzumab combined with daily subcutaneous interleukin 2: Report of cancer and leukemia group B 9661

Clinical Cancer Research

Volumn 8, Issue 12, 2002, Pages 3718-3727

  Fleming, Gini F ^a,g   Meropol, Neal J ^b   Rosner, Gary L ^c   Hollis, Donna R ^c   Carson III, William E ^d   Caligiuri, Michael ^d   Mortimer, Joanne ^e   Tkaczuk, Katherine ^f   Parihar, Robin ^d   Schilsky, Richard L ^a   Ratain, Mark J ^a  

^a UNIVERSITY OF CHICAGO   (United States)

^b FOX CHASE CANCER CENTER   (United States)

^c DUKE UNIVERSITY   (United States)

^d THE OHIO STATE UNIVERSITY WEXNER MEDICAL CENTER   (United States)

^e WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF MARYLAND GREENEBAUM CANCER CENTER   (United States)

^g UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; INTERLEUKIN 2; TRASTUZUMAB;

ADULT; AGED; ARTICLE; BLOOD TOXICITY; BREAST CARCINOMA; CANCER COMBINATION CHEMOTHERAPY; CARCINOMA; CELL LINE; CELL SUBPOPULATION; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOTOXICITY; DIARRHEA; DOSE RESPONSE; DYSPNEA; ERYTHEMA; FATIGUE; FEVER; GASTROINTESTINAL TOXICITY; GENE OVEREXPRESSION; HUMAN; HUMAN CELL; HYPOTENSION; HYPOXIA; INFECTION; LUNG TOXICITY; MAJOR CLINICAL STUDY; MALAISE; MONONUCLEAR CELL; NATURAL KILLER CELL; NAUSEA; NEUTROPENIA; ONCOGENE NEU; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RESPIRATORY DISTRESS; SEPSIS; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIGENS, CD56; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHROMIUM; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLOW CYTOMETRY; HUMANS; IMMUNOENZYME TECHNIQUES; IN SITU HYBRIDIZATION, FLUORESCENCE; INTERLEUKIN-2; KILLER CELLS, NATURAL; MALE; MIDDLE AGED; NEOPLASMS; RECEPTOR, ERBB-2; TREATMENT OUTCOME;

EID: 0036897432     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (18)

1. Baselga, J., Tripathy, D., Mendelsohn, J., et al. Phase II study of weekly intravenous recombinant humanized anti-p185HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. J. Clin. Oncol., 14: 737-744, 1996.
2. Cobleigh, M. A., Vogel, C. L., Tripathy, D., et al. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J. Clin. Oncol., 17: 2639-2648, 1999.
3. Vogel C. L., Cobleigh M. A., Tripathy D., et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-over-expressing metastatic breast cancer. J. Clin. Oncol., 20: 719-726, 2002.
4. Slamon, D. J., Leyland-Jones, B., Shak, S., et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N. Engl. J. Med., 344: 783-792, 2001.
5. Clynes, R. A., Towers, T. L., Presta, L. G., et al. Inhibitory Fc receptors modulate in vivo cytotoxicity against tumor targets. Nat. Med., 6: 443-446, 2000.
6. Hotaling, T. E., Reitz, B., Wolfgang-Kimball, D., et al. The humanized anti-HER2 antibody rhuMAb HER2 mediates antibody dependent cell-mediated cytotoxicity via FcyR III. Proc. Am. Assoc. Cancer Res., 37: 471, 1996.
7. Smith, K. A. Lowest dose interleukin-2 immunotherapy. Blood, 81: 1414-1423, 1993.
8. Caligiuri, M. A., Zmuidzinas, A., Manley, T. J., et al. Functional consequences of interleukin 2 receptor expression on resting human lymphocytes. Identification of a novel natural killer cell subset with high affinity receptors. J. Exp. Med., 171: 1509-1526, 1990.
9. Lindemann, A., Brossart, P., Hoffken, K., et al. Immunomodulatory effects of ultra-low-dose interleukin-2 in cancer patients: A Phase-IB study. Cancer Immunol. Immunother., 37: 307-315, 1993.
10. Caligiuri, M. A., Murray, C., Robertson, M. J., et al. Selective modulation of human natural killer cells in vivo after prolonged infusion of low dose recombinant interleukin 2. J. Clin. Investig., 91: 123-132, 1993.
11. Meropol, N. J., Porter, M., Blumenson, L. E., et al. Daily subcutaneous injection of low-dose interleukin 2 expands natural killer cells in vivo without significant toxicity. Clin. Cancer Res., 2: 669-677, 1996.
12. Meropol, N. J., Barresi, G. M., Fehniger, T. A., et al. Evaluation of natural killer cell expansion and activation in vivo with daily subcutaneous low-dose interleukin-2 plus periodic intermediate-dose pulsing. Cancer Immunol. Immunother., 46: 318-326, 1998.
13. Carter, P., Presta, L., Gorman, C. M., et al. Humanization of an anti-p185HER2 antibody for human cancer therapy. Proc. Natl. Acad. Sci. USA, 89: 4285-4289, 1992.
14. Kasid, A., Director, E. P., and Rosenberg, S. A. Induction of endogenous cytokine-mRNA in circulating peripheral blood mononuclear cells by IL-2 administration to cancer patients. J. Immunol., 143: 736-739, 1989.
15. Platts, K. E., Lawry, J., Hancock, B. W., et al. Phenotypic and cell cycle analysis of human peripheral blood mononuclear cells activated with interleukin-2 and/or OKT3. Exp. Cell Res., 208: 154-160, 1993.
16. Kruskal, W. H., and Wallis, W. A. Use of ranks in one-criterion variance analysis. J. Am. Stat. Assoc., 47: 583-621, 1952.
17. Gelmon, K., Arnold, A., Verma J., et al. Pharmacokinetics (PK) and safety of trastuzumab (Herceptin) when administered every three weeks to women with metastatic breast cancer. Proc. Am. Soc. Clin. Oncol., 20: 69a, 2001.
18. Carson, W. E., Parihar, R., Lindemann, M. J., et al. Interleukin-2 enhances the natural killer cell response to Herceptin-coated Her2/neupositive breast cancer cells. Eur. J. Immunol., 31: 3016-3025, 2001.