|
|
|
|
|
|
||
|
|
||||
|
|
||||
|
||||
Clinical Therapy Trails-Other |
The Brain Tumor Center, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77005
2 Address correspondence and reprint requests to Frederick F. Lang, Department of Neurosurgery, Box 442, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd., Houston, Texas 77030-4009.
Abstract
Although no optimal treatment is currently available for malignant brain tumors, as the molecular mechanisms underlying brain tumor development have been delineated, new chemotherapeutic agents that act directly on specific molecular targets have become available. Defining a specific molecular target raises the possibility that the molecular effects of a given agent can be analyzed in patients in a clinical trial. Specifically, whereas standard phase I and II clinical trials classically determine the safety and efficacy of agents by using indirect global end points, these new biological agents afford the opportunity to incorporate molecular end points into phase I and II clinical trials to determine whether the agent under investigation is actually doing what it was intended to do. This work presents avenues for improving current brain tumor clinical trial designs based on the molecular specificity of new agents and the unique features of brain tumors. Specifically, the authors recommend brain-applicable phase I and II clinical trial strategies that take advantage of the targeted nature of new agents to maximize information about their efficacy, toxicity, and molecular effects.
This article has been cited by other articles:
|
|
 |
|
  S. M. Chang, K. R. Lamborn, J. G. Kuhn, W.K. A. Yung, M. R. Gilbert, P. Y. Wen, H. A. Fine, M. P. Mehta, L. M. DeAngelis, F. S. Lieberman, et al. Neurooncology clinical trial design for targeted therapies: Lessons learned from the North American Brain Tumor Consortium Neuro-oncol, August 1, 2008; 10(4): 631 - 642. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
K. V. Ballman, J. C. Buckner, P. D. Brown, C. Giannini, P. J. Flynn, B. R. LaPlant, and K. A. Jaeckle The relationship between six-month progression-free survival and 12-month overall survival end points for phase II trials in patients with glioblastoma multiforme Neuro-oncol, January 1, 2007; 9(1): 29 - 38. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. B. Heimberger, E. Wang, E. C. McGary, K. R. Hess, V. K. Henry, T. Shono, Z. Cohen, J. Gumin, R. Sawaya, C. A. Conrad, et al. Mechanisms of action of rapamycin in gliomas Neuro-oncol, January 1, 2005; 7(1): 1 - 11. [Abstract] [PDF]
|
|
|
|
 |
|
 V. K. Puduvalli, W.K. A. Yung, K. R. Hess, J. G. Kuhn, M. D. Groves, V. A. Levin, J. Zwiebel, S. M. Chang, T. F. Cloughesy, L. Junck, et al. Phase II Study of Fenretinide (NSC 374551) in Adults With Recurrent Malignant Gliomas: A North American Brain Tumor Consortium Study J. Clin. Oncol., November 1, 2004; 22(21): 4282 - 4289. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. R. Perry and J. G. Cairncross Glioma Therapies: How to Tell Which Work? J. Clin. Oncol., October 1, 2003; 21(19): 3547 - 3549. [Full Text] [PDF]
|
|
|
|
|
|
F. F. Lang, J. M. Bruner, G. N. Fuller, K. Aldape, M. D. Prados, S. Chang, M. S. Berger, M. W. McDermott, S. M. Kunwar, L. R. Junck, et al. Phase I Trial of Adenovirus-Mediated p53 Gene Therapy for Recurrent Glioma: Biological and Clinical Results J. Clin. Oncol., July 1, 2003; 21(13): 2508 - 2518. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. Fueyo, R. Alemany, C. Gomez-Manzano, G. N. Fuller, A. Khan, C. A. Conrad, T.-J. Liu, H. Jiang, M. G. Lemoine, K. Suzuki, et al. Preclinical Characterization of the Antiglioma Activity of a Tropism-Enhanced Adenovirus Targeted to the Retinoblastoma Pathway J Natl Cancer Inst, May 7, 2003; 95(9): 652 - 660. [Abstract] [Full Text] [PDF]
|
|
|
|
