SOLICITATION NOTICE
B -- Study of Depsipeptide in Patients
- Notice Date
- 8/25/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-60173-NG
- Response Due
- 9/11/2006
- Archive Date
- 9/26/2006
- Description
- The National Cancer Institute (NCI), Center for Cancer Research (CCR) plans to procure on a sole source basis, services regarding: Phase II study of Depsipeptide in Patients with Cutaneous and Relapsing Peripheral T-cell Lymphoma with City of Hope, National Medical Center, 1500 E. Durante Road Durante, California 91010. The supplies and services herein are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13. The North American Industry Classification System code is 541380 and the business size standard is $11M. The NCI, CCR studies a large variety of lymphomas and has found depsipeptide (FR901128) to be effective in the clinic and in patients with lymphoma. Depsipeptide is a member of a new class of agents, the histone deacetylase inhibitors (HDI), currently being evaluated in clinical trials. Due to promising activity observed in phase I testing, a phase II trial of depsipeptide is ongoing for patients with cutaneous or peripheral T-cell lymphoma. The first patients (43) were enrolled and treated with depsipeptide at NCI for this phase II trial. It was felt that clearly depsipeptide showed promise as a drug that could become a future therapy for lymphoma but there needed to be a specific number of patients to be sure that this was statistically significant. The conclusive phase II trial will be expanded to institutions throughout the United States and other countries. Specific Project: Clinical Protocol - NCI-01-C-0049: Objectives: 1) determine the response rate and long term clinical effects in patients with cutaneous T-cell lymphoma or relapsed peripheral T-cell lymphoma treated with depsipeptide and 2) Evaluate the molecular effects of depsipeptide in these patients. Patients eligible for this protocol must have: 1) Measurable cutaneous T-cell lymphoma or pheripheral T-cell lymphoma, 2) No CNS lymphoma, 3) Four weeks since prior chemotherapy, 4) Three weeks since prior major surgery and, 5) Performance status: ECOG 0-2. Contractor Requirements: The contractor shall discuss the NCI Clinical Protocol with patients? with cutaneous T-cell lymphoma or relapsed peripheral T-cell lymphoma. If the patient is willing to participate in the study, the contractor shall perform the necessary physicals and testing needed for a baseline assessment of the patient?s condition and to be sure of their eligibility as outlined above. Once patient is enrolled, they will receive depsipeptide and be treated on designed intervals. Patient shall have blood tests, ECGs, MRIs, Muga scans, review of numerous medical records and physical histories. Large medical centers were contacted regarding the Phase II study and the only medical center that responded was The City of Hope. They currently have patients from the West Coast area that are eligible for the Phase II Clinical Protocol and come from a variety of cultural backgrounds which will add to the number of current patient population under this study. As a result of the patients? diverse cultural backgrounds, their diversity will be beneficial to determine the utility of depsipeptide as a future cancer therapy. The City of Hope National Medical Center is the only source known within the United States that have patients eligible for this study. Period of Performance: Award through six (6) months. Only one (1) award will be made. This notice is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Capability statements must be received in the contracting office by 1:00 PM EDT, on September 11, 2006. For further information please contact Malinda Holdcraft, Contract Specialist via electronic mail at holdcram@exchange.nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. No faxed or emailed capability statements will be accepted. In order to receive an award, contractors must be registered in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA). Reference NCI-60173-NG.
- Place of Performance
- Address: California
- Zip Code: 91010
- Country: UNITED STATES
- Zip Code: 91010
- Record
- SN01125647-W 20060827/060825220502 (fbodaily.com)
- Source
-
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