Memorial Sloan-Kettering Cancer Center (MSKCC) and its investigators submit this proposal to perform timely high quality clinical Phase II/III trials of anticancer agents including when possible and appropriate correlative laboratory studies. MSKCC is particularly able to complete high priority trials requiring rapid patient accrual to answer pressing questions of national and internation import in the treatment of patients with cancer. In addition, our clinical trials include the performance of correlative biological studies including pharmacokinetic and pharmacodynamic analysis of new agents and crucially obtaining tissue for analysis of biological markers. Nor counting our commitments to other programs, this proposal documents that from 10/1990 until 12/31/1993 716 eligible patients from MSKCC entered clinical studies supported by the Phase II/III contract, an average of 220 per year. During the period 1/1/1993 to 12/31/1993, 1333 patients were treated on MSKCC IRB approved Phase II/III clinical trials. We also demonstrate our ability to confirm the dose and schedule selected for new agents having completed Phase I trials and beginning early Phase II studies, and our ability to select new agents in a variety of cancers. We have great experience in determining the anti-tumor activity of existing agents at significantly higher than usual doses using colony-stimulating factors or other agents to ameliorate dose limiting toxicity. We also have long experience in defining pharmacokinetic and pharmodynamic correlates to optimize individual dosing and explore other endpoints such as impaired and organ function or heavy prior treatment. Importantly, ancillary basic laboratory studies are an integral part of many of our trials as are quality of life assessments. In addition, we have the ability, when appropriate, to evaluate the costs of selected Phase II trials. The team directing this research has a national and international recognition for its efforts in drug development in the treatment of patients with malignancy.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01CA069913-04S2
Application #
6287788
Study Section
Special Emphasis Panel (NSS)
Program Officer
Arbuck, Susan
Project Start
1995-07-01
Project End
2001-03-31
Budget Start
1998-04-01
Budget End
2001-03-31
Support Year
4
Fiscal Year
2000
Total Cost
$235,515
Indirect Cost
Name
Sloan-Kettering Institute for Cancer Research
Department
Type
DUNS #
064931884
City
New York
State
NY
Country
United States
Zip Code
10065
O'Connor, Owen A; Portlock, Carol; Moskowitz, Craig et al. (2010) Time to treatment response in patients with follicular lymphoma treated with bortezomib is longer compared with other histologic subtypes. Clin Cancer Res 16:719-26
Gerecitano, John; Portlock, Carol; Moskowitz, Craig et al. (2009) Phase 2 study of weekly bortezomib in mantle cell and follicular lymphoma. Br J Haematol 146:652-5
O'Connor, Owen A; Moskowitz, Craig; Portlock, Carol et al. (2009) Patients with chemotherapy-refractory mantle cell lymphoma experience high response rates and identical progression-free survivals compared with patients with relapsed disease following treatment with single agent bortezomib: results of a multicentre Phas Br J Haematol 145:34-9
O'Connor, Owen A; Portlock, Carol; Moskowitz, Craig et al. (2008) A multicentre phase II clinical experience with the novel aza-epothilone Ixabepilone (BMS247550) in patients with relapsed or refractory indolent non-Hodgkin lymphoma and mantle cell lymphoma. Br J Haematol 143:201-9
Stubblefield, M D; Slovin, S; MacGregor-Cortelli, B et al. (2006) An electrodiagnostic evaluation of the effect of pre-existing peripheral nervous system disorders in patients treated with the novel proteasome inhibitor bortezomib. Clin Oncol (R Coll Radiol) 18:410-8
Paoluzzi, Luca; O'Connor, Owen A (2006) Mechanistic rationale and clinical evidence for the efficacy of proteasome inhibitors against indolent and mantle cell lymphomas. BioDrugs 20:13-23
Gerecitano, John; Goy, Andre; Wright, John et al. (2006) Drug-induced cutaneous vasculitis in patients with non-Hodgkin lymphoma treated with the novel proteasome inhibitor bortezomib: a possible surrogate marker of response? Br J Haematol 134:391-8
Su, Yungpo Bernard; Vickers, Andrew J; Zelefsky, Michael J et al. (2006) Double-blind, placebo-controlled, randomized trial of granulocyte-colony stimulating factor during postoperative radiotherapy for squamous head and neck cancer. Cancer J 12:182-8
O'Connor, Owen A (2005) Developing new drugs for the treatment of lymphoma. Eur J Haematol Suppl :150-8
O'Connor, Owen A (2005) Marked clinical activity of the proteasome inhibitor bortezomib in patients with follicular and mantle-cell lymphoma. Clin Lymphoma Myeloma 6:191-9

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