Correlation of toxicity with treatment parameters for 131I-CC49 radioimmunotherapy in three phase II clinical trials

Cancer Biotherapy and Radiopharmaceuticals

Volumn 12, Issue 2, 1997, Pages 79-87

  Liu, Tiepu ^a   Meredith, Ruby F ^b,d   Saleh, Mansoor N ^a   Wheeler, Richard H ^a   Khazaeli, M B ^a   Plott, Walter E ^b   Schlom, Jeffrey ^c   LoBuglio, Albert F ^a  

^a University of Alabama at Birmingham   (United States)

^b The University of Alabama at Birmingham   (United States)

^c NATIONAL CANCER INSTITUTE   (United States)

^d UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

Author keywords

Biostatistics; Cancer; Clinical trials; Monoclonal antibody; Radioimmunotherapy; Toxicity

Indexed keywords

CARCINOEMBRYONIC ANTIGEN MONOCLONAL ANTIBODY; IODINE 131; MONOCLONAL ANTIBODY CC49; RECOMBINANT ALPHA2B INTERFERON; RECOMBINANT INTERLEUKIN 1BETA;

ADULT; AGED; ARTICLE; BLOOD TOXICITY; BONE MARROW SUPPRESSION; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; COLON CANCER; FEMALE; FEVER; HUMAN; HYPOTENSION; INTRAVENOUS DRUG ADMINISTRATION; MALE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; RADIATION DOSE; RADIOIMMUNOTHERAPY; WHOLE BODY RADIATION;

EID: 0030809651     PISSN: 10849785     EISSN: None     Source Type: Journal    
DOI: 10.1089/cbr.1997.12.79     Document Type: Article

References (23)

1. Breitz HB, Fisher DR and Wessels B. Correlation of bone marrow absorbed dose estimates with marrow toxicity. Tumor Targeting 1996;2:173. (Abstract #74)
2. Coffey JL and Watson EE. Calculating dose from remaining body activity: A comparison of two methods. Med Phys 1979,6:307-308.
3. Divgi CR, Scott A M, Dantis L, et al. Phase I radioimmunotherapy trial with I-131-CC49 in metastatic colon carcinoma. J Nucl Med 1995;36:586-592
4. 131I-labeled anti-CEA monoclonal antibodies. Tumor Targeting 1996;2:164. (Abstract #55)
5. Labaune JP. Handbook of Pharmacokinetics, Toxicity Assessment of Chemicals, John Wiley & Sons, New York, 1989.
6. Laird NM and Ware JH Random-effects models for longitudinal data. Biometrics 1982;38:963-974.
7. Leichner PK, Akabani G. Colcher D, et al Patient-specific dosimetry of indium-111-/yttrium-90-labeled monoclonal antibody CC49 J Nucl Med (In press).
8. Liu T. Characteristics of pharmacokinetics modeling in a phase I clinical trial of radiolabeled monoclonal antibody Controlled Clin. Trials 1991;12:654-655.
9. Loevinger R and Berman MA A Revised Schema for Calculating the Absorbed Dose from Biologically Distributed Radionuclides MIRD Pamphlet No. 1, Society of Nuclear Medicine, New York. 1976.
10. Meredith RF, Bueschen AJ, Khazaeli MB, et al (1994) Treatment of metastatic prostate carcinoma with radiolabeled antibody CC49 J Nucl. Med. 35, 1017-1022.
11. Meredith RF, Khazaeli MB, Plott WE, et al. Phase II study of dual 131-I-labeled monoclonal antibody therapy with interferon in patients with metastatic colorectal cancer. Clin. Cancer Res. 1996;2:1811-1818.
12. Meredith RF, LoBuglio AF, Plott WE, et al. Pharmacokinetics, immune response and biodistribution of iodine-131-labeled chimeric mouse/human IgG1 ,K 17-1A monoclonal antibody. J Nucl Med 1991;32:1162-1168.
13. Muraro R, Kuroki M, Wunderlich D, et al. Generation and charactenzation of B72.3 second generation monoclonal antibodies reactive with TAG-72 antigen. Cancer Res 1988;48:4588-4596
14. Murray JL, Macey DJ, Kasi LD, et al Phase II radioimmunotherapy trial with 131-I-CC49 in colorectal cancer Cancer 1994;73 (Suppl):1057-1066.
15. SAS/STAT User's Guide (1989) Version 6, Fourth Edition, Volume 1 & 2, SAS Institute, Inc , Cary, NC.
16. Sgouros G Bone marrow dosimetry for radioimmunotherapy: Theoretical considerations. J Nucl Med 1993;34:689-694.
17. Snedecor GW and Cochran WG Statistical Methods, Seventh Edition. The Iowa State University Press, Ames, IA, 1980
18. Snyder WS, Ford MR and Warner GG. Estimates of specific absorbed fractions for photon sources uniformly distributed in various organs of a heterogeneous phantom MIRD Pamphlet No. 5, Society of Nuclear Medicine, New York, 1978.
19. Snyder WS, Ford MR, Warner GG and Watson SB. "s", absorbed dose per unit cumulated activity for selected radionuclides and organs. MIRD Pamphlet No. 11, Society of Nuclear Medicine, New York. 1975.
20. Wheeler RH, Meredith RF, Saleh MN, et al. A phase II trial of IL-1 +radioimmunotherapy (RIT) in patients (pts) with metastatic colon cancer. Proceedings ASCO 1994;13:295. (Abstract#959)
21. Yu B, Carrasquillo J, Milenic D, et al. Phase I trial of 131-I-COL-1 in patients with gastrointestinal (GI) malignancies: Influence of serum CEA on pharmacokinetics. Proceedings ASCO 1993;12:292. (Abstract)
22. Zasadny KR, Gates VL, Fisher SJ, Kaminski MS and Wahl RL. J Nucl Med 1995;36:214P (Abstract #962)
23. ZhangR, Liu T, Soong S-j and Diasio RB A mathematical model of kinetics and disposition of 2-fluoro-β-alanine, the major metabolite of 5-fluorouracil. Biochem Pharm 1993;45:2063-2069.