Oral sodium phenylbutyrate in patients with recurrent malignant gliomas: A dose escalation and pharmacologic study

Neuro-Oncology

Volumn 7, Issue 2, 2005, Pages 177-182

  Phuphanich, Surasak ^a,d   Baker, Sharyn D ^b   Grossman, Stuart A ^b   Carson, Kathryn A ^b   Gilbert, Mark R ^c   Fisher, Joy D ^b   Carducci, Michael A ^b  

^a EMORY UNIVERSITY   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d NABTT CNS Consortium   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT; ARYLBUTYRIC ACID DERIVATIVE; CYTOCHROME P450;

ADULT; AGED; ARTICLE; BLOOD TOXICITY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG POTENTIATION; DRUG TOLERABILITY; FATIGUE; FEMALE; GLIOBLASTOMA; HEADACHE; HUMAN; MALE; MAXIMUM TOLERATED DOSE; RECURRENT CANCER; SOMNOLENCE;

ADMINISTRATION, ORAL; ADULT; AGED; ANTICONVULSANTS; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; CYTOCHROME P-450 ENZYME SYSTEM; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INTERACTIONS; FEMALE; GLIOMA; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; PHENYLBUTYRATES; SUPRATENTORIAL NEOPLASMS;

EID: 17844410310     PISSN: 15228517     EISSN: None     Source Type: Journal    
DOI: 10.1215/S1152851704000183     Document Type: Article

References (22)

1. Baker, M.J., Brem, S., Daniels, S., Sherman, B., and Phuphanich, S. (2002) Complete response of a recurrent, multicentric malignant glioma in a patient treated with phenylbutyrate. J. Neurooncol. 59, 239-242.
2. Batchelor, T.T., Gilbert, M.R., Supko, J.G., Carson, K.A., Nabors, L.B., Grossman, S.A., Lesser, G.J., Mikkelsen, T., and Phuphanich, S. (2004) Phase 2 study of weekly irinotecan in adults with recurrent malignant glioma: Final report of NABTT 97-11. Neuro-Oncol. 6, 21-27
3. Buckner, J.C., Malkin, M.G., Reed, E., Cascino, T.L., Reid, J.M., Ames, M.M., Tong, W.P., Lim, S., and Figg, W.D. (1999) Phase II study of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in patients with recurrent glioma. Mayo Clin. Proc. 74, 137-145.
4. Carducci, M.A., Nelson, J.B., Chan-Tack, K.M., Ayyagari, S.R., Sweatt, W.H., Campbell, P.A., Nelson, W.G., and Simons, J.W. (1996) Phenylbutyrate induces apoptosis in human prostate cancer and is more potent than phenylacetate. Clin. Cancer Res. 2, 379-387.
5. Carducci, M.A., Gilbert, J., Bowling, M.K., Noe, D., Eisenberger, M.A., Sinibaldi, V., Zabelina, Y., Chen, T.L., Grochow, L.B., and Donehower, R.C. (2001) A phase I clinical and pharmacological evaluation of sodium phenylbutyrate on a 120-h infusion schedule. Clin. Cancer Res. 7, 3047-3055.
6. Chang, S.M., Kuhn, J.G., Robins, H.I., Schold, S.C., Spence, A.M., Berger, M.S., Mehta, M.P., Bozik, M.E., Pollack, I., Schiff, D., Gilbert, M., Rankin, C., and Prados, M.D. (1999) Phase II study of phenylacetate in patients with recurrent malignant glioma: A North American Brain Tumor Consortium report. J. Clin. Oncol. 17, 984-990.
7. Dmitrovsky, E., Markman, M., and Marks, P.A. (1990) Clinical use of differentiating agents in cancer therapy. Cancer Chemother. Biol. Response Modif. 11, 303-320.
8. Fetell, M.R., Grossman, S.A., Fisher, J.D., Erlanger, B., Rowinsky, E., Stockel, J., and Piantadosi, S. (1997) Preirradiation paclitaxel in glioblastoma multiforme: Efficacy, pharmacology, and drug interactions. New Approaches to Brain Tumor Therapy Central Nervous System Consortium. J. Clin. Oncol. 15, 3121-3128.
9. Gibaldi, M., and Perrier, D. (1982) Noncompartmental analysis based on statistical moment theory. Chapter 11 in Pharmacokinetics. New York: Marcel Dekker. pp. 409-417.
10. Gilbert, J., Baker, S.D., Bowling, M.K., Grochow, L., Figg, W.D., Zabelina, Y., Donehower, R.C., and Carducci, M.A. (2001) A phase I dose escalation and bioavailability study of oral sodium phenylbutyrate in patients with refractory solid tumor malignancies. Clin. Cancer Res. 7, 2292-2300.
11. Gilbert, M.R., Supko, J.G., Batchelor, T., Lessor, G., Fisher, J.D., Piantadosi, S., and Grossman, S.A. (2003) Phase I clinical and pharmacokinetic study of irinotecan in adults with recurrent glioma. Clin. Cancer Res. 9, 2940-2949.
12. Gore, S.D., Samid, D., and Weng, L.J. (1997a) Impact of the putative differentiating agents sodium phenylbutyrate and sodium phenylacetate on proliferation, differentiation, and apoptosis of primary neoplastic myeloid cells. Clin. Cancer Res. 3, 1755-1762.
13. Gore, S.D., Miller, C.B., Weng, L.J., Burks, K., Griffin, C.A., Chen, T.-L., Smith, V., Burke, P.J., Grever, M., and Rowinsky, E.K. (1997b) Clinical development of sodium phenylbutyrate as a putative differentiating agent in myeloid malignancies. Anticancer Res. 17, 3938 (abstract 29).
14. Gore, S.D., Weng, L.J., Figg, W.D., Zhai, S. Donehower, R.C., Dover, G., Grever, M.R., Griffin, C., Grochow, L.B., Hawkins, A., Burks, K., Zabelena, Y., and Miller, C.B. (2002) Impact of prolonged infusions of the putative differentiating agent sodium phenylbutyrate on myelodysplastic syndromes and acute myeloid leukemia. Clin. Cancer Res. 8, 963-970.
15. Grossman, S.A., Fisher, J.D., Piantadosi, S., and Brem, H. (1998a) The New Approaches to Brain Tumor Therapy (NABTT) CNS Consortium: Organization, objectives, and activities. Cancer Control 5, 107-114.
16. Grossman, S.A., Hochberg, F., Fisher, J., Chen, T.L., Kim, L., Gregory, R., Grochow, L.B., and Piantadosi, S. (1998b) Increased 9-aminocamptothecin dose requirements in patients on anticonvulsants. Cancer Chemother. Pharmacol. 42, 118-126.
17. Hudgins, W.R., Pineau, T., Sher, T., Gonzales, F.J., Myers, C.E., and Samid, D. (1994) Anticancer activity of phenylacetate and related aromatic fatty acids: Correlation with lipophilicity and capacity to activate nuclear receptor. Proc. Am. Assoc. Can. Res. 35, 391 (abstract 2332).
18. Kaplan, E.L., and Meier, P. (1958) Nonparametric estimation from incomplete observations. J. Am. Stat. Assoc. 53, 457-481.
19. Samid, D., Shack, S., and Myers, C.E. (1993) Selective growth arrest and phenotypic reversion of prostate cancer cells in vitro by nontoxic pharmacological concentrations of phenylacetate. J. Clin. Invest. 91, 2288-2295.
20. Samid, D., Ram, Z., Hudgins, W.R., Shack, S., Liu, L., Walbridge, S., Oldfield, E.H., and Myers, C.E. (1994) Selective activity of phenylacetate against malignant gliomas: Resemblance to fetal brain damage in phenylketonuria. Cancer Res. 54, 891-895.
21. Sidell, N., Wada, R., Han, G., Chang, B., Shack, S., Moore, T., and Samid, D. (1995) Phenylacetate synergizes with retinoic acid in inducing the differentiation of human neuroblastoma cells. Int. J. Cancer 60, 507-514.
22. Warrell, R.P., Jr., He, L.Z., Richon, V., Calleja, E., and Pandolfi, P.P. (1998) Therapeutic targeting of transcription in acute promyelocytic leukemia by use of an inhibitor of histone deacetylase. J. Natl. Cancer Inst. 90, 1621-1625.