Skip to main content

New drug delivery approach for the treatment of prostate cancer (preclinical results and phase I study results).

Publication ,  Journal Article
Dhawan, M; Price, D; Trump, D; Kanter, P; Shore, N; Needham, D; Dewhirst, M
Published in: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
July 2004

4661 Introduction: Treatment for localized prostate cancer includes observation, radiation and surgical therapy with or without androgen deprivation.. One potential relevant form of therapy is thermal therapy plus thermally sensitive liposomal encapsulated cytotoxic agents administered systemically, concentrated in the prostate, where the focused heat triggers drug release from the liposome.Extensive animal studies were performed in rodents and dogs to support the ongoing clinical study for the treatment of Prostate cancer . A study in dogs tested whether the BPH800 System, a transurethral microwave catheter heating system, would heat the prostate to temperatures high enough to activate the heat-sensitive liposomes. Detailed large and small animal toxicology studies were also performed. Preclinical Results: The drug is active against a range of xenografts, including PC3, a prostate tumor line, when the tumor region is heated to temperatures that lead to rapid drug release from the liposomes. Enhanced growth delay was observed, when compared with heat alone and drug alone. Dog studies demonstrated that the BPH800 System is capable of providing safe and reliable thermal therapy in that it consistently applied the heat needed to maintain the prostate at the liposomal drug-release temperature of 41°C-42°C for 60 minutes. The toxicology studies in large dogs established that the DLT was slightly lower than that of free drug. These data were used to design the starting dose for Phase I trials.The preclinical study results led to FDA clearance to conduct the first Phase I dose escalation trial to determine the MTD, PK, & safety of Thermadox™ when activated with thermal therapy for the treatment of prostate cancer. The study is currently in process and will be completed in early 2004. The poster will describe the framework of the Phase I study and its results.Assessment of the safety and efficacy of the treatment of prostate cancer is in progress; enrollment is continuing for the first Phase I study. [Table: see text].

Duke Scholars

Published In

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

EISSN

1527-7755

ISSN

0732-183X

Publication Date

July 2004

Volume

22

Issue

14_suppl

Start / End Page

4661

Related Subject Headings

  • Oncology & Carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Dhawan, M., Price, D., Trump, D., Kanter, P., Shore, N., Needham, D., & Dewhirst, M. (2004). New drug delivery approach for the treatment of prostate cancer (preclinical results and phase I study results). Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 22(14_suppl), 4661.
Dhawan, M., D. Price, D. Trump, P. Kanter, N. Shore, D. Needham, and M. Dewhirst. “New drug delivery approach for the treatment of prostate cancer (preclinical results and phase I study results).Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology 22, no. 14_suppl (July 2004): 4661.
Dhawan M, Price D, Trump D, Kanter P, Shore N, Needham D, et al. New drug delivery approach for the treatment of prostate cancer (preclinical results and phase I study results). Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2004 Jul;22(14_suppl):4661.
Dhawan, M., et al. “New drug delivery approach for the treatment of prostate cancer (preclinical results and phase I study results).Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 22, no. 14_suppl, July 2004, p. 4661.
Dhawan M, Price D, Trump D, Kanter P, Shore N, Needham D, Dewhirst M. New drug delivery approach for the treatment of prostate cancer (preclinical results and phase I study results). Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2004 Jul;22(14_suppl):4661.

Published In

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

EISSN

1527-7755

ISSN

0732-183X

Publication Date

July 2004

Volume

22

Issue

14_suppl

Start / End Page

4661

Related Subject Headings

  • Oncology & Carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences