A phase I study of the vitamin D 3 analogue ILX23-7553 administered orally to Patients with advanced solid tumors

Investigational New Drugs

Volumn 29, Issue 6, 2011, Pages 1420-1425

  Jain, Rajul K ^a   Trump, Donald L ^b   Egorin, Merrill J ^c,d   Fernandez, Manuel ^e   Johnson, Candace S ^b   Ramanathan, Ramesh K ^f  

^a UNIVERSITY OF TEXAS   (United States)

^b ROSWELL PARK CANCER INSTITUTE   (United States)

^c UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^e GENZYME CORPORATION   (United States)

^f Virginia G Piper Cancer Center   (United States)

Author keywords

Calcitriol; Cancer; Oncology; Phase I; Vitamin D

Indexed keywords

9,10 SECOCHOLESTA 5,7,10(19),16 TETRAEN 23 YNE 1,3,25 TRIOL; ILX 23 7553; UNCLASSIFIED DRUG; ANTINEOPLASTIC AGENT; COLECALCIFEROL; DRUG DERIVATIVE; ILX237553;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADRENAL CORTEX CARCINOMA; ADULT; ADVANCED CANCER; AGED; ANIMAL EXPERIMENT; ANIMAL MODEL; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTHRALGIA; ARTICLE; BENIGN TUMOR; CANCER CHEMOTHERAPY; CANCER INHIBITION; COLON CANCER; CONSTIPATION; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG FATALITY; DRUG FORMULATION; DRUG MECHANISM; DRUG MEGADOSE; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; DRUG USE; FATIGUE; FEMALE; GASTROINTESTINAL DISEASE; HUMAN; IN VITRO STUDY; LOOSE FECES; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NONHUMAN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; RADIOIMMUNOASSAY; RADIORECEPTOR ASSAY; RECOMMENDED DRUG DOSE; SIDE EFFECT; SOLID TUMOR; XEROSTOMIA; CLINICAL TRIAL; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM; ORAL DRUG ADMINISTRATION; PATHOLOGY; RADIOASSAY; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CHOLECALCIFEROL; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; RADIOIMMUNOASSAY; RADIOLIGAND ASSAY; TREATMENT OUTCOME;

EID: 84856032626     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-010-9492-5     Document Type: Article

References (28)

1. Eisman JA, Martin TJ, MacIntyre I, Moseley JM (1979) 1, 25-dihydroxyvitamin-D-receptor in breast cancer cells. Lancet 2:1335-6
2. Findlay DM, Michelangeli VP, Eisman JA et al (1980) Calcitonin and 1, 25-dihydroxyvitamin D3 receptors in human breast cancer cell lines. Cancer Res 40:4764-7 (Pubitemid 11199751)
3. Frampton RJ, Suva LJ, Eisman JA et al (1982) Presence of 1, 25-dihydroxyvitamin D3 receptors in established human cancer cell lines in culture. Cancer Res 42:1116-9 (Pubitemid 12141229)
4. Sher E, Eisman JA, Moseley JM, Martin TJ (1981) Whole-cell uptake and nuclear localization of 1, 25-dihydroxycholecalciferol by breast cancer cells (T47 D) in culture. Biochem J 1(200):315-20 (Pubitemid 12218254)
5. Sher E, Martin TJ, Eisman JA (1985) Hormone-dependent transformation and nuclear localisation of 1, 25-dihydroxyvitamin D3 receptors from human breast cancer cell lines and chick duodenum. Horm Metab Res 17:147-51 (Pubitemid 15107234)
6. Ravid A, Koren R, Novogrodsky A, Liberman UA (1984) 1, 25-Dihydroxyvitamin D3 inhibits selectively the mitogenic stimulation of mouse medullary thymocytes. Biochem Biophys Res Commun 1123:163-9 (Pubitemid 14031104)
7. Bar-Shavit Z, Teitelbaum SL, Reitsma P et al (1983) Induction of monocytic differentiation and bone resorption by 1, 25-dihydroxyvitamin D3. Proc Natl Acad Sci USA 80:5907-11 (Pubitemid 14227581)
8. Colston K, Colston MJ, Feldman D (1981) 1, 25-dihydroxyvitamin D3 and malignant melanoma: the presence of receptors and inhibition of cell growth in culture. Endocrinology 108:1083-6 (Pubitemid 11142302)
9. Eisman JA, Frampton RJ, McLean FJ (1986) Biochemical significance of enhanced activity of fluorinated 1, 25-dihydroxyvitamin D3 in human cultured cell lines. Cell Biochem Funct 4:115-22 (Pubitemid 16140109)
10. Cross HS, Pavelka M, Slavik J, Peterlik M (1992) Growth control of human colon cancer cells by vitamin D and calcium in vitro. J Natl Cancer Inst 84:1355-7
11. Honma Y, Hozumi M, Abe E et al (1983) 1 alpha, 25-Dihydroxyvitamin D3 and 1 alpha-hydroxyvitamin D3 prolong survival time of mice inoculated with myeloid leukemia cells. Proc Natl Acad Sci USA 80:201-4 (Pubitemid 13221836)
12. Eisman JA, Barkla DH, Tutton PJ (1987) Suppression of in vivo growth of human cancer solid tumor xenografts by 1, 25-dihydroxyvitamin D3. Cancer Res 47:21-5 (Pubitemid 17002091)
13. Koeffler HP, Hirji K, Itri L (1985) 1, 25-Dihydroxyvitamin D3: in vivo and in vitro effects on human preleukemic and leukemic cells. Cancer Treat Rep 69:1399-407 (Pubitemid 16163079)
14. Slapak CA, Desforges JF, Fogaren T, Miller KB (1992) Treatment of acute myeloid leukemia in the elderly with low-dose cytarabine, hydroxyurea, and calcitriol. Am J Hematol 41:178-83
15. De Rosa L, Montuoro A, De Laurenzi A (1992) Therapy of 'high risk' myelodysplastic syndromes with an association of low-dose Ara-C, retinoic acid and 1, 25-dihydroxyvitamin D3. Biomed Pharmacother 46:211-7
16. Schwartz GG, Hall MC, Stindt D et al (2005) Phase I/II study of 19-nor-1alpha-25-dihydroxyvitamin D2 (paricalcitol) in advanced, androgen-insensitive prostate cancer. Clin Cancer Res 11:8680-5 (Pubitemid 43005917)
17. Beer TM, Munar M, Henner WD (2001) A Phase I trial of pulse calcitriol in patients with refractory malignancies: pulse dosing permits substantial dose escalation. Cancer 91:2431-9 (Pubitemid 32552832)
18. Muindi JR, Peng Y, Potter DM et al (2002) Pharmacokinetics of high-dose oral calcitriol: results from a phase 1 trial of calcitriol and paclitaxel. Clin Pharmacol Ther 72:648-59 (Pubitemid 36021004)
19. Smith DC, Johnson CS, Freeman CC et al (1999) A Phase I trial of calcitriol (1, 25-dihydroxycholecalciferol) in patients with advanced malignancy. Clin Cancer Res 5:1339-45 (Pubitemid 29282937)
20. Fakih MG, Trump DL, Muindi JR et al (2007) A phase I pharmacokinetic and pharmacodynamic study of intravenous calcitriol in combination with oral gefitinib in patients with advanced solid tumors. Clin Cancer Res 13:1216-23 (Pubitemid 46424063)
21. Muindi JR, Johnson CS, Trump DL et al (2009) A phase I and pharmacokinetics study of intravenous calcitriol in combination with oral dexamethasone and gefitinib in patients with advanced solid tumors. Cancer Chemother Pharmacol 56:33-40
22. Zhou JY, Norman AW, Lubbert M et al (1989) Novel vitamin D analogs that modulate leukemic cell growth and differentiation with little effect on either intestinal calcium absorption or bone mobilization. Blood 74:82-93 (Pubitemid 19187413)
23. Wang Q, Yang W, Uytingco MS et al (2000) 1, 25-Dihydroxyvitamin D3 and all-trans-retinoic acid sensitize breast cancer cells to chemotherapy-induced cell death. Cancer Res 60:2040-8 (Pubitemid 30207668)
24. Zhou JY, Norman AW, Chen DL et al (1990) 1, 25-Dihydroxy-16-ene-23-yne- vitamin D3 prolongs survival time of leukemic mice. Proc Natl Acad Sci USA 87:3929-32
25. Hollis BW (1986) Assay of circulating 1, 25-dihydroxyvitamin D involving a novel single-cartridge extraction and purification procedure. Clin Chem 32:2060-3 (Pubitemid 17029196)
26. Hollis BW, Kamerud JQ, Kurkowski A et al (1996) Quantification of circulating 1, 25-dihydroxyvitamin D by radioimmunoassay with 125I-labeled tracer. Clin Chem 42:586-92
27. Wieder R, Novick SC, Hollis BW et al (2003) Pharmacokinetics and safety of ILX23-7553, a non-calcemic-vitamin D3 analogue, in a phase I study of patients with advanced malignancies. Invest New Drugs 21:445-52 (Pubitemid 38124984)
28. Beer TM, Javle MM, Ryan CW et al (2007) Phase I study of weekly DN-101, a new formulation of calcitriol, in patients with cancer. Cancer Chemother Pharmacol 59:581-7 (Pubitemid 46295122)