SOLICITATION NOTICE
A -- Evaluation of Efficacy and Mechanisms of an Antiinflammitory Intervention for Chemotherapy-Related Mucosal Injury - SOW and TEC
- Notice Date
- 8/19/2009
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, 5th Floor, Rockville, Maryland, 20852-3804, United States
- ZIP Code
- 20852-3804
- Solicitation Number
- NIHNINR20090522-P
- Point of Contact
- Louis A Kuta, Sr., Phone: 301-496-8024
- E-Mail Address
-
louis.kuta@nih.gov
(louis.kuta@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Statement of Work and Tecnical Evaluation Criteria The National Institute of Nursing Research, National Institutes of Health, intends to award a contract with the University of Maryland Greenebaum Cancer Center to conduct a Phase II randomized controlled clinical trial, “Evaluation of Efficacy and Mechanisms of an Antiinflammatory Intervention for Chemotherapy-Related Mucosal Injury” (02-NR-0133), which is evaluating the efficiency and toxicity of an investigational mouthwash for the attenuation of conditioning chemotherapy related stomatitis during hematopoietic stem cell transplantation (HSCT) treatment. The key element of this clinical trial involves subject application of etanercept mouthwash 2.5 mg four times daily beginning the day before HSCT and continuing until stomatitis and oral pain resolution or at BMT day +14 or day of discharge, whichever comes first. This is a unique scientific opportunity to study the efficacy and toxicity of a novel agent for treatment of conditioning chemotherapy related stomatitis over the course of HSCT. The protocol was IRB approved in 2002. The key elements of this project include administration of an investigational agent per protocol, and assessment of stomatitis and oropharyngeal pain, and collection of saliva, oral buccal brushing, and blood samples at baseline, and BMT days -2, +2, +5, +7, +9, +12, +14 continuing until stomatitis and oral pain resolution or at BMT day +14 or day of discharge, whichever comes first. A Statement of Work, including Technical Evaluation Factors, accompanies this notice in FBO. Responsible sources may submit a proposal by 03 September 2009, 4:00 PM EST, which shall be considered by NIH. This requirement was previously presented under Sources Sought Notice NIHNINR20090522.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/OoA/NIHNINR20090522-P/listing.html)
- Record
- SN01918410-W 20090821/090820001311-4c4fa20b5dae167e3ed6882b51bec1df (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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