SOLICITATION NOTICE
B -- Patient Enrollment Testing for the Depsipeptide Phase II Clinical Trial
- Notice Date
- 8/22/2008
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-80173-MM
- Archive Date
- 9/20/2008
- Point of Contact
- Melissa P Marino, Phone: 301-402-4509, Caren N Rasmussen,, Phone: (301) 402-4509
- E-Mail Address
-
marinome@mail.nih.gov, cr214i@nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR) intends to procure on a sole-source basis with Sir Charles Gairdner Hospital, Hospital Avenue, Ground Floor Block E, Nedlands Western Australia 6009 and with the University of Pittsburgh, 190 Lothrop Street, Suite 101, Pittsburgh, PA 15213 for services regarding Phase II Study of Depsipeptide in Patients with Cutaneous and Relapsing Peripheral T-cell Lymphoma. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System Code is 541690 and the business size standard is $6.5M Period of performance: Performance shall be for two months from date of award.. Overall Program. The Molecular Therapeutics Section of the Medical Oncology Branch is the Center for Cancer Research at the NCI studies a large variety of lymphomas. NCI has found depsipeptide (FR901128) to be effective in the clinic, in patients with lymphoma. 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 contractor shall discuss protocol NCI-01-C-0049 with each of their patients with cutaneous T-cell lymphoma or relapsed peripheral T-cell lymphoma who could be eligible for this clinical trial. If the patient is willing to participate in the study, the contractor shall perform the required testing and physicals needed for a baseline assessment of the patient's condition and to be sure of their eligibility for the study. The testing to be performed has a dual purpose, but this initial testing is to ensure the patients meet the health requirements to participate in the protocol. Once eligibility is established the patient will receive depsipeptide and be treated on designed intervals. The participating hospital shall report only the number of patients enrolled and their data to NCI. In an effort to acquire a larger and more diverse population for this important study of depsipeptide, NCI contacted over 25 large medical institutions. Many facilities were interested in the study but were not able to find patients that would be willing to be enrolled in a research study. Dr. David Joske at Sir Charles Gairdner Cancer Center in Australia surveyed the patients at his facility. He was able to find 6 patients with lymphoma who are interested in enrolling in this Phase II Clinical Trial. Dr. Larisa Geskins at the University of Pittsburg in Pennsylvania surveyed the patients at her facility. She was able to find 10 patients with lymphoma who are interested in enrolling in this Phase II Clinical Trial. These individuals are from Australia and other places in the world and are from a variety of cultural backgrounds, thus they would add to the numbers of the current patient population on the study and to the diversity of the population already in the study making Sir Charles Gairdner Hospital and the University of Pittsburgh uniquely qualified to participate. Therefore, adding these individuals would be beneficial to determine the utility of depsipeptide as a future cancer therapy. Market research determined that these two facilities were the only two with patients with lymphoma who were willing to participate in this study. This is not a solicitation for competitive quotations. Two awards shall be made as a result of this pre-solicitation. However, if any interested party believes it can meet the above requirement, they may submit a request for solicitation or a statement of capabilities. All information furnished shall be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NCI contracting office by 1:00 PM EDT on September 5, 2008. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Melissa Marino, Contract Specialist at marinome@mail.nih.gov. It is the vendor's responsibility to call (301) 402-4509 to verify questions have been received. A determination by the Government not to compete this proposed contract 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. In order to receive an award, contractors must have valid registration/certification in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference NCI-80173-MM on all correspondence.
- Web Link
-
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- Record
- SN01648635-W 20080824/080822222431-917cfe0de51e350e17561d5d9d5ea792 (fbodaily.com)
- Source
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