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Tumor bed implant for simultaneous heat and radiation of resectable brain tumors

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA239815-01A1
Agency Tracking Number: R41CA239815
Amount: $300,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 100
Solicitation Number: PA18-575
Timeline
Solicitation Year: 2018
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-07-01
Award End Date (Contract End Date): 2021-06-30
Small Business Information
119 N ROAD
Deerfield, NH 03037-1107
United States
DUNS: 079465752
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 PAUL STAUFFER
 (919) 668-7419
 paul.stauffer@duke.edu
Business Contact
 JANET KWIATKOWSKI
Phone: (603) 340-7079
Email: janetk@maegroups.com
Research Institution
 THOMAS JEFFERSON UNIVERSITY
 
833 CHESTNUT STREET, SUITE 900
PHILADELPHIA, PA 19107-4418
United States

 Nonprofit College or University
Abstract

Abstract / Summary
Glioblastoma multiforme (GBM) is an aggressive brain tumor that generally recurs locally and has a median
survival andlt;18 months. Treatment typically involves surgery followed by radiation and chemotherapy but the
challenge remains to provide sufficient radiation dose to sterilize tumor bed without unacceptable toxicity in
surrounding normal brain. A randomized clinical trial studying brachytherapy radiation boost to tumor bed with
and without sequentially applied local heat showed a doubling of two-year survival in GBM compared to
brachytherapy alone. Although that 31% two-year survival rate is higher than current state of the art treatment
approaches for GBM, previous thermobrachytherapy studies used University prototype heating systems that
were never commercialized, and thus the approach was discontinued. With alternative treatments still failing to
match prior results, the time has come to optimize thermobrachytherapy. Ensuing in vivo studies have shown
that synergy between heat (HT) and radiation (RT) is maximized when the two therapies are applied
simultaneously. To meet the urgent need for improved survival following brain tumor surgery, we propose a
dual-modality thermobrachytherapy (TBT) balloon implant to fill the resection cavity and further increase the
survival benefit seen in prior studies by: i) delivering HT and RT more uniformly to tumor bed; ii) providing
potent thermal enhancement of RT response up to 5X in tumor bed by combining HT and RT simultaneously;
iii) beginning RT of tumor bed immediately after surgery before tumor cell migration; and iv) improving patient
satisfaction and reducing cost by decreasing treatment time from 3-6 weeks of daily external beam RT to andlt;5
days total therapy. Our premise is that by applying local heat and brachytherapy simultaneously for maximum
synergy and uniformly to the resection cavity wall for effective localization of effect before tumor cells migrate,
we can significantly enhance local response and survival while minimizing peripheral toxicity and thereby
improve clinical outcomes. Our Phase I development has three specific aims: i) to fabricate a dual-therapy
balloon device; ii) to evaluate the device for compatibility of HT and RT components and characterize thermal
and radiation dosimetry in laboratory studies; and iii) demonstrate appropriate heat distributions that coincide
with computer treatment plans in in vivo animal perfused tissue studies. After demonstrating safety and
effectiveness in followup clinical trials in Phase II, we anticipate neurosurgeons and oncologists associated
with ~250 brain surgery centers already owning HDR afterloaders will embrace this new technology due to
obvious need for improved therapy in andgt;52,000 resected brain tumors annually in the US, impressive clinical
precedent in GBM with inferior thermobrachytherapy approaches, and established regulatory pathway for
component technologies. While this development is focused towards brain tumor therapy, the TBT balloon
procedure is expected to find application in other tumor resection sites including head and neck, breast, lung,
and sarcoma (with potentially ~600,000 patients annually in US) following successful launch in brain tumors.The proposed research is relevant to public health since it addresses a solution to an all too common and
unfortunately dismal prognosis – brain tumor. The project is relevant to NCIandapos;s mission because it will facilitate a
novel treatment approach with certain clinical benefit as shown by previous clinical trials using predicate
technologies. Based on earlier work, the proposed development presents a clear pathway through clinical trials
and regulatory approvals en route to providing improved clinical outcomes at lower cost for andgt;52,000 patients/year
in the US with primary glioblastoma and other life-shortening recurrent and metastatic resectable brain tumors.

* Information listed above is at the time of submission. *

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