Pharmacokinetics of interstitial delivery of carmustine, 4- hydroperoxycyclophosphamide, and paclitaxel from a biodegradable polymer implant in the monkey brain

Cancer Research

Volumn 58, Issue 4, 1998, Pages 672-684

  Fung, Lawrence K ^a   Ewend, Matthew G ^b   Sills, Allen ^b   Sipos, Eric P ^b   Thompson, Reid ^b   Watts, Mark ^b   Colvin, O Michael ^c   Brem, Henry ^b   Saltzman, W Mark ^a  

^a Cornell University   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

4 HYDROPEROXYCYCLOPHOSPHAMIDE; CARMUSTINE; PACLITAXEL;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; AUTORADIOGRAPHY; BIODEGRADATION; CANCER SURVIVAL; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; DRUG RELEASE; GLIOMA; IMPLANT; IMPLANTATION; NONHUMAN; PRIORITY JOURNAL;

ANIMALS; ANTINEOPLASTIC AGENTS; BIODEGRADATION, ENVIRONMENTAL; BRAIN; CAPSULES; CARMUSTINE; CYCLOPHOSPHAMIDE; DRUG IMPLANTS; MACACA FASCICULARIS; MALE; PACLITAXEL; POLYMERS;

EID: 0032520051     PISSN: 00085472     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (64)

1. Brem, H., Mahaley, S. M., Jr., Vick, N. A., Black, K. L., Schold, S. C., Jr., Burger, P. C., Friedman, A. H., Ciric, I. S., Eller, T. W., Cozzens, J. W., and Keneally, J. N. Interstitial chemotherapy with drug polymer implants for the treatment of recurrent gliomas J. Neurosurg., 74: 441-446, 1991.
2. Brem, H., Piantadosi, S., Burger, P. C., Walker, M., Selker, R., Vick, N. A., Black, K., Sisti, M., Brem, S., Mohr, G., Muller, P., Morawetz, R., and Schold, S. C. Placebo-controlled trial of safety and efficacy of intraoperative controlled delivery by biodegradable polymers of chemotherapy for recurrent gliomas. Lancet, 345: 1008-1012, 1995.
3. Tamargo, R. J., Myseros, J. S., Epstein, J. I., Yang, M. B., Chasin, M., and Brem, H. Interstitial chemotherapy of the 9L gliosarcoma: controlled release polymers for drug delivery in the brain. Cancer Res., 53: 329-333, 1993.
4. Sipos, E. P., Tyler, B., Piantadosi, S., Burger, P. C., and Brem, H. Optimizing interstitial delivery of BCNU from controlled release polymers for the treatment of brain tumors. Cancer Chemother. Pharmacol., 39: 383-389, 1997.
5. Judy, K. D., Olivi, A., Buahin, K. G., Domb, A., Epstein, J. I., Colvin, O. M., and Brem, H. Effectiveness of controlled release of a cyclophosphamide derivative with polymers against rat gliomas. J. Neurosurg., 82: 481-486, 1995.
6. Walter, K. A., Cahan, M. A., Gur, A., Tyler, B., Hilton, J., Colvin, O. M., Burger, P. C., Domb, A., and Brem, H. Interstitial Taxol delivery from a biodegradable polymer implant against malignant glioma. Cancer Res., 54: 2207-2212, 1994.
7. Weingart, J. D., Thompson, R. C., Tyler, B., Colvin, O. M., and Brem, H. Local delivery of the topoisomerase I inhibitor camptothecin sodium prolongs survival in the rat intracranial 9L gliosarcoma model. Int. J. Cancer, 62: 605-609, 1995.
8. Weingart, J. D., Sipos, E. P., and Brem, H. The role of minocycline in the treatment of intracranial 9L glioma. J. Neurosurg., 82: 635-640, 1995.
9. Olivi, A., Ewend, M. G., Utsuki, T., Tyler, B., Domb, A. J., Brat, D. J., and Brem, H. Interstitial delivery of carboplatin via biodegradable polymers is effective against experimental glioma in the rat. Cancer Chemother. Pharmacol., 39: 90-96, 1996.
10. Ewend, M. G., Williams, J. A., Tabassi, K., Tyler, B. M., Babel, K. M., Anderson, R. C., Pinn, M. L., Brat, D. J., and Brem, H. Local delivery of chemotherapy and concurrent external beam radiotherapy prolongs survival in metastatic brain tumor models. Cancer Res., 56: 5217-5223, 1996.
11. Giese, A., and Westphal, M. Glioma invasion in the central nervous system. Neurosurgery, 39: 235-252, 1996.
12. Hochberg, F. H., and Pruitt, A. Assumptions in the radiotherapy of glioblastoma. Neurology, 30: 907-911, 1980.
13. Wallner, K. E., Galicich, J. H., Krol, G., Arbit, E., and Malkin, M. G. Patterns of failure following treatment of glioblastoma multiforme and anaplastic astrocytoma. J. Radiat. Oncol. Biol. Phys., 16: 1405-1409, 1989.
14. Fung, L. K., Shin, M., Tyler, B., Brem, H., and Saltzman, W. M. Chemotherapeutic drugs released from polymers: distribution of 1,3-bis(2-chloroethyl)-1-nitrosourea in the rat brain. Pharm. Res., 13: 671-682, 1996.
15. Strasser, J. F., Fung, L. K., Eller, S., Grossman, S. A., and Saltzman, W. M. Distribution of 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) and tracers in the rabbit brain after interstitial delivery by biodegradable polymer implants. J. Pharmacol. Exp. Ther. 275: 1647-1655, 1995.
16. Grossman, S. A., Reinhard, C., Colvin, M., Chasin, M., Brundrett, R., Tamargo, R. J., and Brem, H. The intracerebral distribution of BCNU delivered by surgically implanted biodegradable polymers. J. Neurosurg., 76: 640-647, 1992.
17. Domb, A. J., Rock, M., Schwartz, J., Perkin, C., Yipchuk, G., Broxup, B., and Villemure, J. G. Metabolic disposition and elimination studies of a radiolabelled biodegradable polymeric implant in the rat brain. Biomaterials, 15: 681-688, 1994.
18. Buahin, K. G., Judy, K. D., Hartke, C., Domb, A. J., Maniar, M., Colvin, O. M., and Brem, H. Controlled release of 4-hydroperoxycyclophosphamide from the fatty acid dimer-sebacic acid copolymer. Polymers Adv. Technol., 3: 311-316, 1992.
19. Zon, G., Ludeman, S. M., Brandt, J. A., Boyd, V. L., Ozkan, G., Egan, W., and Shao, K. L. NMR spectroscopic studies of intermediary metabolites of cyclophosphamide: a comprehensive kinetic analysis of the interconversion of cis- and trans-4-hydroxycyclophosphamide with aldophosphamide and the concomitant partitioning of aldophosphamide between irreversible fragmentation and reversible conjugation pathways. J. Med. Chem., 27: 266-285, 1984.
20. Langer, R. Polymeric delivery systems for controlled drug release. Chem. Eng. Commun., 6: 1-48, 1980.
21. Nicholson, C. Interaction between diffusion and Michaelis-Menten uptake of dopamine after ionophoresis in striatum. Biophys. J., 68: 1699-1715, 1995.
22. Rosomoff, H. Method for simultaneous quantitative estimation of intracranial contents. J. Appl. Physiol., 16: 395-396, 1961.
23. Wu, M. P., Tamada, J. A., Brem, H., and Langer, R. In vivo versus in vitro degradation of controlled release polymers for intracranial surgical therapy. J. Biomed. Materials Res., 28: 387-395, 1994.
24. Leo, A., Mansch, C., and Elkins, D. Partition coefficients and their uses. Chem. Rev., 71: 525-616, 1971.
25. Shabel, F. M., Johnston, T. P., McCaleb, G. S., Montgomery, J. A., Laster, W. R., and Skipper, H. E. Experimental evaluation of potential anti-cancer agents. VII. Effects of certain nitrosoureas on intracerebral L121O leukemia. Cancer Res., 23: 725-733, 1963.
26. Loo, T. L., Dixon, R. L., and Rall, D. P. The antitumor agent, 1,3-bis(2-chloroethyl)-1-nitrosourea. J. Pharm. Sci., 55: 492-497, 1966.
27. Kanter, P. M., Schwartz, H. S., and West, C. R. Functional and chemical markers of PCNU activity. Cancer Drug Delivery, 1: 11-20, 1983.
28. Blasberg, R. G., Patlak, C., and Fenstermacher, J. D. Intrathecal chemotherapy: brain tissue profiles after ventriculocisternal perfusion. J. Pharmacol Exp. Ther., 195: 73-83, 1975.
29. Reulen, H. J., Graham, R., Fenske, M., Tsuyumu, M., and Klatzo, I. The role of tissue pressure and bulk flow in the formation and resolution of cold-induced edema. In: H. M. Pappius and W. Feindel (ed.), Dynamics of Brain Edema, pp. 103-112. Berlin: Springer-Verlag, 1976.
30. Reulen, H. J., Graham, R., Spatz, M., and Klatzo, I. Role of pressure gradients and bulk flow in dynamics of vasogenic brain edema. J. Neurosurg., 46: 24-35, 1977.
31. Reulen, H. J., Tsuyumu, M., Tack, A., Fenske, A. R., and Prioleau, G. R. Clearance of edema fluid into cerebrospinal fluid. J. Neurosurg., 48: 754-764, 1978.
32. Yang, G. Y., Betz, A. L., Chenevert, T. L., Brunberg, J. A., and Hoff, J. T. Experimental intracerebral hemorrhage: relationship between brain edema, blood flow, and blood-brain barrier permeability in rats. J. Neurosurg., 81: 93-102, 1994.
33. Ferszt, R., Neu, S., Cervos-Navarro, J., and Sperner, J. The spreading of focal brain edema induced by ultraviolet irradiation. Acta Neuropathol., 42: 223-229, 1978.
34. Quencer, R. M., Post, M. J., and Hinks, R. S. Cine MR in the evaluation of normal and abnormal CSF flow: intracranial and intraspinal studies. Neuroradiology, 32: 371-391, 1990.
35. Renkin, E. M. Cellular and intercellular transport pathways in exchange vessels. Am. Rev. Respir. Dis., 146: S28-S31, 1992.
36. Jain, R. K. Determinants of tumor blood flow: a review. Cancer Res., 48: 2641-2658, 1988.
37. Renkin, E. M. Transport pathways through capillary endothelium. Microvasc. Res., 15: 123-135, 1978.
38. Renkin, E. M. Multiple pathways of capillary permeability. Circ. Res., 41: 735-743, 1977.
39. Jaeger, C. B., Winn, S. R., Tresco, P. A., and Aebischer, P. Repair of the blood-brain barrier following implantation of polymer capsules. Brain Res., 551: 163-170, 1991.
40. Oldfield, E. H., Dedrick, R. L., Chatterji, D. C., Yeager, R. L., Girton, M. E., Kornblith, P. L., and Doppman, J. L. Arterial drug infusion with extracorporeal removal. II. Internal carotid carmustine in rhesus monkeys. Cancer Treat. Rep., 69: 293-303, 1985.
41. Henner, W. D., Peters, W. P., Eder, J. P., Antman, K., Schnipper, L., and Frei, E. Pharmacokinetics and immediate effects of high-dose carmustine in man. Cancer Treat. Rep., 70: 877-880, 1986.
42. Shapiro, W. R., Grenn, S. B., Burger, P. C., Selker, R. G., VanGilder, J. C., Robertson, J. T., Mealey, J. J., Ransohoff, J., and Mahaley, M. S. A randomized comparison of intra-arterial versus intravenous BCNU, with or without intravenous 5-fluorouracil, for newly diagnosed patient with malignant glioma. J. Neurosurg., 76: 772-781, 1992.
43. Fung, L. K., Ewend, M., Sills, A., Sipos, E., Thompson, R., Watts, M., Brem, H., and Saltzman, W. M. Carmustine distribution following Gliadel polymer implantation and interstitial release in the primate brain. In: First Scientific Meeting for the Society of Neuro-Oncology, Santa Fe, NM. Houston, TX: Society of Neuro-Oncology, 1996.
44. Fung, L. K., Hilton, J., Colvin, O. M., and Saltzman, W. M. Cylotoxic effects of low-dose, long-term exposure of BCNU in human glioma cells in culture. In: Second Annual Scientific Meeting for the Society for Neuro-Oncology, Charlottesville, VA. Houston, TX: Society of Neuro-Oncology, 1997.
45. Ketchum, R. E. B., and Gibson, D. M. Rapid isocratic reversed phase HPLC of taxanes on new columns developed specifically for Taxol analysis. J. Liquid Chromatogr., 16: 2519-2530, 1993.
46. Levin, V. A., Hoffman, W., and Weinkam, R. J. Pharmacokinetics of BCNU in man: a preliminary study of 20 patients. Cancer Treat. Rep., 62: 1305-1312, 1978.
47. Gerlowski, L. E., and Jain, R. Physiologically based pharmacological modeling: principles and applications (Review). J. Pharm. Sci., 72: 1103-1127, 1983.
48. Levin, V. A. Relationship of octanol/water partition coefficient and molecular weight to rat brain capillary permeability. J. Med. Chem., 23: 682-684, 1980.
49. Rapoport, S. I., Ohno, K., and Pettigrew, K. D. Drug entry into the brain. Brain Res., 172: 354-359, 1979.
50. Rowinsky, E. K., Wright, M., Monsarrat, B., Lesser, G. J., and Donehower, R. C. Taxol: pharmacology, metabolism and clinical implications. Cancer Surv., 17: 283-304, 1993.
51. Friedman, H. S., Colvin, O. M., Ludeman, S. M., Schold, S. C., Boyd, V. L., Mulhbaier, L. H., and Bigner, D. D. Experimental chemotherapy of human medulloblastoma with classical alkylators. Cancer Res., 46: 2877-2833, 1986.
52. Heimans, J. J., Vermerken, J. B., Wolbers, J. G., Eeltink, C. M., Meijer, W. M., Taphoorn, M. J. B., and Beijnen, J. H. Paclitaxel (Taxol) concentrations in brain tumor tissue. Ann. Oncol., 5: 951-953, 1994.
53. Arndt, C. A. S., Colvin, O. M., Balis, F. M., McCully, C. L., Johnston, G., and Poplack, D. G. Intrathecal administration of 4-hydroxycyclophosphamide in rhesus monkeys. Cancer Res., 47: 5932-5934: 1987.
54. 1-acid glycoprotein. Res. Commun. Chem. Pathol. Pharmacol., 80: 337-344, 1993.
55. 6-methylguanine in DNA to inactivation by alkylating agents including chloroethylnitrosoureas. Cancer Res., 44: 2467-2474, 1984.
56. Domeyer, B. E., and Sladek, N. E. Kinetics of cyclophosphamide biotransformation in vivo. Cancer Res., 40: 174-180, 1980.
57. Rahman, A., Korzekwa, K. R., Grogan, J., Gonzalez, F. J., and Harris, J. W. Selective biotransformation of Taxol to 6α-hydroxytaxol by human cytochrome P450 2C8. Cancer Res., 54: 5543-5546, 1994.
58. Kumar, G., Ray, S., Walle, T., Haung, Y., Willingham, M., Self, S., and Bhalla, K. Comparative in vitro cytotoxic effects of Taxol and its major human metabolite 6α-hydroxytaxol. Cancer Chemother. Pharmacol., 36: 129-135, 1995.
59. Pratt, W. B., Ruddon, R. W., Ensminger, W. D., and Maybaum, J. The Anticancer Drugs, Ed. 2, pp. 108-154. New York: Oxford University Press, 1994.
60. Hunter, K. J., Deen, D. F., Pellarin, M., and Marton, L. J. Effect of α-difluoromethylornithine on 1,3-bis(2-chloroethyl)-1-nitrosourea and cis-diamminedichloro-platinum(II) cytotoxicity, DNA interstrand cross-linking, and growth in human tumor cell lines in vitro. Cancer Res., 50: 2769-2772, 1990.
61. Cahan, M. A., Walter, K. A., Colvin, O. M., and Brem, H. Cytotoxicity of Taxol in vitro against human and rat malignant tumors. Cancer Chemother. Pharmacol., 33: 441-444, 1994.
62. Berne, R. M., and Levy, M. N. The arterial system. In: R. M. Berne and M. N. Levy (eds.), Physiology, pp. 486-507. St. Louis, MO: C. V. Mosby Co., 1988.
63. Wiedeman, M. P. Architecture. In: E. M. Renkin and C. C. Michel (eds.), The Cardiovascular System, Vol. IV, pp. 11-40. Bethesda, MD: American Physiological Society, 1984.
64. Rosenberg, G. A., Kyner, W. T., and Estrada, E. Bulk flow of brain interstitial fluid under normal and hyperosmolar conditions. Am. J. Physiol., 238: F42-F49, 1980.