A phase I trial of calcitriol (1,25-dihydroxycholecalciferol) in patients with advanced malignancy

Clinical Cancer Research

Volumn 5, Issue 6, 1999, Pages 1339-1345

  Smith, David C ^a,b   Johnson, Candace S ^a   Freeman, Catherine C ^a   Muindi, Josephia ^a   Wilson, John W ^a   Trump, Donald L ^a,c  

^a UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^b UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^c MUH N723 ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CALCITRIOL; VITAMIN D RECEPTOR;

ADOLESCENT; ADULT; ADVANCED CANCER; AGED; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CANCER INHIBITION; CANCER THERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG HALF LIFE; DRUG INDICATION; DRUG TOLERABILITY; FEMALE; HUMAN; HYPERCALCEMIA; MALE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SUBCUTANEOUS DRUG ADMINISTRATION; VITAMIN BLOOD LEVEL;

ADENOCARCINOMA; ADOLESCENT; ADULT; AGED; AREA UNDER CURVE; CALCITRIOL; CALCIUM; CARCINOEMBRYONIC ANTIGEN; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; HYPERCALCEMIA; MALE; MIDDLE AGED; NEOPLASMS; PARATHYROID HORMONE; RADIOIMMUNOASSAY;

EID: 0032978243     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (47)

1. Garland, C. F., and Garland, F. C. Do sunlight and vitamin D reduce the risk of colon cancer? Int. J. Epidemiol., 9: 227-231, 1980.
2. Schwartz, G. G., and Hulka, B. S. Is vitamin D deficiency a risk factor for prostate cancer? Anticancer Res., 10: 1307-1312, 1990.
3. Corder, E. H., Guess, H. A., Hulka, B. S., Freidman, G. D. Sadler, M., Vollmer, R. T., Lobaugh, B., Drezner, M. K., Vogelman, J. H., and Orentriech, N. Vitamin D and prostate cancer: a prediagnostic study with stored sera. Cancer Epidemiol. Biomark. Prev., 2: 467-472, 1993.
4. Garland, C. F., Garland, F. C., Shaw, E. K., Comstock, G. W., Helsing, K. J., and Gorham, E. D. Serum 25-hydroxyvitamin D and colon cancer: eight-year prospective study. Lancet, 2: 1176-1178, 1989.
5. Garland, C. F., Shekelle, R. B., and Barrett-Connor, E.,. Vitamin D and calcium and risk of colorectal cancer: a 19-year prospective study in men. Lancet, 1: 307-309, 1985.
6. Ingles, S. A., Haile, R., Henderson, B. Kolonel, L., and Coetzee, G. Association of vitamin D receptor genetic polymorphism with breast cancer risk in African-American and Hispanic women. In: A. W. Norman, (ed.), Vitamin D: Chemistry, Biology and Clinical Applications, pp. 813-814. Riverside, CA: University of California Printing, 1997.
7. Ingles, S. A., Ross, R. K., Yu, M. C., Irvine, R. A., LaPera, G., Haile, R. W., and Coetzee, G. A. Association of prostate cancer risk with genetic polymorphisms in vitamin D receptor and androgen receptor. J. Natl. Cancer Inst. (Bethesda), 89: 166-170, 1997.
8. 3 and malignant melanoma: the presence of receptors and inhibition of cell growth in culture. Endocrinology, 108: 1083-1086, 1981.
9. 3 inhibitory effect on the growth of two human breast cancer cell lines (MCF-7, BT-20). J. Steroid Biochem., 24: 373-376, 1986.
10. Cross, H. S., Pavelka, M., Slavik, J., and Peterlik, M. Growth control of human colon cancer cells by vitamin D and calcium in vitro. J. Natl. Cancer Inst. (Bethesda), 84: 1355-1357, 1992.
11. 3 receptors and actions in human prostate cancer cell lines. Endocrinology, 132: 1952-1960, 1993.
12. Johnson, C. S., McElwain, M. C., Light, B. W., Yu, W. D., Modzelewski, R. A., Trump, D. L., and Getzenberg, R. H. Antiproliferative effects of vitamin D and its analogues in rodent tumor models. In: A. W. Norman, (ed.), Vitamin D: Chemistry, Biology and Clinical Applications, pp. 451-458. Riverside, CA: University of California Printing, 1997.
13. Light, B. W., Yu, W. D., McElwain, M. C., Russell, D. M., Trump, D. L., and Johnson, C. S. Potentiation of cisplatin antitumor activity using a vitamin D analogue in a murine squamous cell carcinoma model system. Cancer Res., 57: 3759-3764, 1997.
14. 3. Cancer Res., 47: 21-25, 1987.
15. 3. Cancer Res., 52: 515-520, 1992.
16. Thomas, M. G., Tebbutt, S., and Williamson, R. C. N. Vitamin D and its metabolites inhibit cell proliferation in human rectal mucosa and a colon cancer cell line. Gut., 33: 1660-1663, 1992.
17. 3 on primary cultures of human prostatic cells. Cancer Res., 54: 805-810, 1994.
18. Getzenberg, R. H., Light, B. W., Lapco, P. E., Konety, B. R., Nangia, A. K., Acierno, J. R., Jr., Dir, R., Shurin, Z., Day, R. S., Trump, D. L., and Johnson, C. S. Vitamin D inhibition of prostate adenocarcinoma growth and metastasis in the Dunning rat prostate model system. Urology, 50: 999-1006, 1997.
19. 3 analogue in a squamous cell carcinoma model system. Mol. Cell. Differ., 3: 31-50, 1995.
20. Konety, B. R., Schwartz, G. G., Acierno, J. R., Jr., Becich, M. J., and Getzenberg, R. H. The role of vitamin D in normal prostate growth and differentiation. Cell Growth Differ., 7: 1563-1157, 1996.
21. 3-untreated antitumor activity with dexamethasone. J. Natl. Cancer Inst. (Bethesda), 90: 134-141, 1998.
22. Zhao, X., and Feldman, D. Regulation of vitamin D receptor abundance and responsiveness during differentiation of HT-29 human colon cancer cells. Endocrinology, 132: 1808-1814, 1993.
23. 3 receptor in human breast cancer. Cancer Res., 41: 5121-5124, 1981.
24. 3 receptors in breast cancer and their relationship to biochemical and clinical indices. Cancer Res., 44: 1677-1681, 1984.
25. 3 receptors and human colon adenocarcinoma. Br. J. Surg., 78: 435-439, 1991.
26. Freake, H. C., and MacIntyre, I. Specific binding of 1,25-dihydroxycholecalciferol in human medullary thyroid carcinoma. Biochem. J., 206: 181-184, 1982.
27. 3 in gynecologic neoplasms. Gynecol. Oncol., 44: 131-136, 1992.
28. Eisman, J. A., MacIntyre, I., Martin, T. J., and Moseley, J. M. 1,25-dihydroxyvitamin-D receptor in breast cancer cells. Lancet, 2: 1335-1336, 1979.
29. 3 receptors in human epithelial cancer cell lines. Cancer Res., 42: 856-859, 1982.
30. 3 receptors in established human cancer cell lines in culture. Cancer Res., 42: 1116-1119, 1982.
31. 3 signaling. Nature (Lond.), 355: 446-449, 1992.
32. 3 inhibits the clonogenic growth of transformed cells via its receptor. Biochem. Biophys. Res. Commun., 139: 136-143, 1986.
33. 3: in vivo and in vitro effects on human preleukemic and leukemic cells. Cancer Treat. Rep., 69: 1399-1407, 1985.
34. Slapak, C. A., Desforges, J. F., Fogaren, T., and Miller, K. B. Treatment of acute myeloid leukemia in the elderly with low-dose cytarabine, hydroxyurea, and calcitriol. Am. J. Hematol., 41: 178-183, 1992.
35. 3. Biomed. Pharm., 46: 211-217, 1992.
36. Osborn, J. L., Schwartz, G. G., Smith, D. C., Bahnson, R., Day, R., and Trump, D. L. Phase II trial of oral 1,25-dihydroxyvitamin D (calcitriol) in hormone refractory prostate cancer. Urol. Oncol., 1: 195-198, 1995.
37. Davies, M. High-dose vitamin D therapy. Indications, benefits and hazards. In: P. Walter, G. Brubacher, and H. Stahelin (eds.), Elevated Dosages of Vitamins, pp 81-86. Lewistown, NY: Hans Huber, 1989.
38. Salusky, I. B., Goodman, W. G., Horst, R., Segre, G. V., Kim, L., Norris, K. C., Adams, J. S., Holloway, M., Fine, R. N., and Coburn, J. W. Pharmacokinetics of calcitriol in continuous ambulatory and cycling peritoneal dialysis patients. Am. J. Kidney Dis., 16: 126-132, 1990.
39. Selgas, R., Martinez, M. E., Miranda, B., Bajo, M. A., Romero, J. R., Ausejo, M., Sanchez-Cabezudo, M. J., Lopez-Revuelta, K., and Sanchez-Sicilia, L. The pharmacokinetics of a single dose of calcitriol administered subcutaneously in continuous ambulatory peritoneal dialysis patients. Peritoneal Dialysis Int., 13: 122-125, 1996.
40. Rolla, D., Paoletti, E., Marsano, L., Mulas, D., Peloso, G., and Cannella, G. Effects of subcutaneous calcitriol administration on plasma calcium and parathyroid hormone concentrations in continuous ambulatory peritoneal dialysis uremic patients. Peritoneal Dialysis Int., 13: 118-121, 1993.
41. Tallarida, R. J., and Murray, R B. In: Manual of Pharmacologie Calculation with Computer Programs, pp. 197-291. New York: Springer-Verlag, 1986.
42. 125-labelled tracer. Eur. J. Clin. Chem. Clin. Biochem., 33: 959-963, 1995.
43. Levine, B. S., and Song, M. Pharmacokinetics and efficiency of pulse oral versus intravenous calcitriol in hemodialysis patients. J. Am. Soc. Nephrol., 7: 488-496, 1996.
44. Mason, R. S., Lissner, D., Posen, S., and Norman, A. W. Blood concentrations of dihydroxylated vitamin D metabolites after an oral dose. Br. Med. J., 1: 449-450, 1980.
45. Gallagher, J. C., Riggs, B. L., Eisman, J., Hamstra, A., Amaud, S. B., and DeLuca, H. F. Intestinal calcium absorption and serum vitamin D metabolites in normal subjects and osteoporotic patients. J. Clin. Invest., 64: 729-736, 1979.
46. 2-vitamin D concentrations and net intestinal calcium, phosphate and magnesium absorption in humans 1-3. Am. J. Clin. Nutr., 32: 2052-2060, 1979.
47. Hamberg, K. J., and Moiler, S. A Phase I study of EB 1089, a vitamin D analogue in healthy subjects. In: A. W. Norman, (ed.), Vitamin D: Chemistry, Biology and Clinical Applications, pp. 491-492. Riverside, CA: University of California Printing, 1997.