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Development of a Perfusion-induced Systemic Hyperthermia Delivery Apparatus

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
85380
Program Year/Program:
2007 / STTR
Agency Tracking Number:
CA120616
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
Michigan Critical Care Consultants, Inc.
3550 West Liberty Suite 3 Ann Arbor, MI -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2007
Title: Development of a Perfusion-induced Systemic Hyperthermia Delivery Apparatus
Agency: HHS
Contract: 1R41CA120616-01A2
Award Amount: $205,583.00
 

Abstract:

DESCRIPTION (provided by applicant): Lung cancer is the leading cause of cancer-related deaths in both men and women in the US today, responsible for 28% of all cancer-related deaths. Long-term prognosis for patients with advanced stage non- small cell lung cancer, present in 75% of new cases, is dismal with a 9-12 month median survival. Future improvements are likely to come from concurrent combined/adjunctive modality treatments or newer directed' agents. The application of exogenously induced he at (hyperthermia) has been proposed as an adjunctive agent. Our long-term goal is to develop treatments that are more effective for patients with metastatic lung cancer. Based on our basic science research, we studied and modified a perfusion-based method for delivering heat to the entire body, then proceeded with an FDA-approved phase I study. This redesigned system, resulted in delivery of a documented therapeutic hyperthermic dose with homogenous distribution of heat throughout the body. Serious mechanic al deficiencies were noted in the system however, the parent company declared this unit obsolete. Based on our basic science and animal data, and encouraged by the results of the clinical trial, UTMB has decided on further development of a hyperthermia del ivery system the objective of this proposal. In order to do so we have partnered with MC3 a research and design company and will address three Specific Aims: Specific Aim 1: Build a working prototype circuit of vv-PISH for the delivery of hyperthermia with the following features: 1) the non-occlusive peristaltic roller pump, 2) an efficient pediatric heat exchanger, 3) a hemofilter selected to achieve adequate ion exchange, and 4) a control system to regulate energy transfer and to monitor the system for sa fety. Specific Aim 2: The system will be bench-tested for safety and temperature control performance. Specific Aim 3: Apply the new vv-PISH prototype circuit in healthy swine (n=10) to achieve core temperature of 420C for 2 hours then recover the animal, a nd study the following: 1) safety of new system, 2) efficiency of heat transfer and, 3) stability of serum electrolytes maintained by the vv-PISH device. The immediate goal of this research plan is to address needed improvements in the original design and produce a device capable of delivering predictable therapeutic doses of hyperthermia safely. In phase II, we will perform a prospective, randomized trial comparing current standard of care to current standard of care plus hyperthermia in stage IV lung canc er. The goal of this project is to develop a clinical system for inducing full body hyperthermia to treat metastatic lung cancer. The system is based on a Phase I clinical trial demonstrating the efficacy of such a treatment.

Principal Investigator:

Roger A. Vertrees
4097728629
RVERTREE@UTMB.EDU

Business Contact:

Kathryn R. Osterholxer
koster@mc3corp.com
Small Business Information at Submission:

MC3, INC.
MC3, INC. 3550 W LIBERTY RD, STE 3 ANN ARBOR, MI 48103

EIN/Tax ID: 382667222
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
Research Institution Information:
UNIVERSITY OF TEXAS MEDICAL BR
UNIVERSITY OF TEXAS HLTH SCI CTR
BOX 20036
HOUSTON, TX 77225 3098
RI Type: Nonprofit college or university