Group Title: Link : clinical trials newsletter
Title: Link ; vol. 1
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Permanent Link: http://ufdc.ufl.edu/UF00088872/00001
 Material Information
Title: Link ; vol. 1
Series Title: Link
Physical Description: Serial
Language: English
Creator: Shands Cancer Center, University of Florida
Wingard, John R.
Publisher: University of Florida Shands Cancer Center
Place of Publication: Gainesville, Fla.
Publication Date: Fall 2005
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Subject: University of Florida.   ( lcsh )
Spatial Coverage: North America -- United States of America -- Florida
 Record Information
Bibliographic ID: UF00088872
Volume ID: VID00001
Source Institution: University of Florida
Holding Location: University of Florida
Rights Management: All rights reserved, Board of Trustees of the University of Florida

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hu min h CLINICAL TRIALS NEWSLETTER
VOLUME 1 FALL 2005


Through clinical research, the new therapies of tomorrow move ever
closer to today.
The University of Florida Shands Cancer Center stands at
the forefront of an exciting time in scientific discovery that
will ultimately have an incredible impact on patient lives. Our
physicians, scientists, staff and technicians both in Gainesville and
Jacksonville are teamed up and dedicated to partnering with our
colleagues in the community to help cancer patients across the
State and the Southeast.
Our optimism for future advances in cancer research has been
strengthened by the unparalleled commitment of the University
of Florida and Shands Healthcare. We have recruited more than
sixty national cancer researchers throughout the past four years. A new cancer
research building, providing 200,000 square feet of new research space, will open
in the spring of 2006. The fifth proton beam therapy facility in the United States
will open July 2006 on UF's Jacksonville campus. Renovations are underway at
both campuses that will provide patients and their families with a more accessible
and pleasant clinical care environment. Finally, a 200-bed cancer hospital on UF's
Gainesville campus, that will consolidate all inpatient and outpatient cancer services,
is scheduled to open mid-2009. The UF Shands Cancer Center is firmly committed
to being at the forefront of defining the new cancer therapies of tomorrow, while
bringing these new discoveries to the citizens of Florida and beyond.
This is the inaugural issue of The Link, our clinical trials newsletter. This and each
subsequent newsletter will highlight some of the exciting and innovative clinical trials
underway at our Center. The goal is to alert clinicians of investigative studies that
may be of interest or benefit to practitioners and their patients. In this first issue,
the focus is on clinical trials for patients with hematologic malignancies, specifically
myleodysplastic syndrome (MDS), leukemia, lymphoma and multiple myeloma. A
complete listing of all of our clinical trials can be obtained by calling 1-888-254-7581
or consulting the Center's Web site at ufscc.ufl.edu.
John R. Wingard, M.D.
Deputy Director, Gainesville


University of Florida
Shands Cancer Center


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Targeted therapy brings new hope for researchers and patients with hematologic
malignancies
While the new cytotoxic agents rightfully continue to be tested in the clinics, there is no doubt
that we have entered the era of target-specific antineoplastic compounds. It is a great hope
that these drugs, either alone or in combination, will be able to change the natural history of the
disease and offer patients with diseases, such as MDS, CML or CLL, a chance of sustained benefit.

The researchers at the University of Florida Shands Cancer Center join the world-wide effort in
developing new therapeutic strategies for patients with hematologic malignancies, incorporating
new, rationally designed, target-specific drugs.


Randomized Multicenter Trial of
Oral SCIO-469 in Patients with
Myelodysplastic Syndromes (MDS).
MDS is a clonal disorder of hematopoietic stem
cells characterized by ineffective hematopoiesis
and eventual transformation into rapidly fatal
acute leukemia. The conventional therapeutic
agents have never shown much effectiveness in
treatment of MDS, and the patients were generally
treated with supportive care. The progressive
unraveling of the array of pathophysiologic
pathways in MDS over the past several years has
led to identification of new molecular treatment
targets and development of a number of novel,
target-specific therapeutic agents, such as
inhibitors of farnesyl transferases (Ras inhibitors)
and receptor tyrosine kinases, angiogenesis
inhibitors and others.
Our center is participating in a large multicenter
study of an oral drug SCIO-469, designed to
target a p38 Mitogen Activated Protein Kinase
(MAPK). MAPK is an enzyme regulating an
overproduction of proinflammatory cytokines
(IFN-a, -f and -y, TGF-f, TNF-a, IL-18), thought
responsible for increased apoptosis in patients
with early stages of MDS. We are particularly
excited about this study since for the first time
we have a well tolerated oral drug designed to
prevent progression of the disease rather than
treatment of late complications. Participation in
this trial offers a perfect opportunity for patients
with low/intermediate-1 risk, who feel strongly
about doing something about their disease before
it becomes too late.


New Promising Bcr-Abl Tyrosine Kinase
Inhibitor to Treat Imatinib Mesylate
(Gleevec) Resistant Chronic Myeloid
Leukemia (CML) and Ph(+)ALL
Despite the great success achieved with
imatinib mesylate in CML, a small but significant
number of patients treated with this agent fail to
respond, develop resistance or become intolerant
to imatinib. Some of the known mechanisms of
resistance are Bcr-Abl-dependent (i.e., mutations
of the Bcr-Abl sequence, amplification or
overexpression of Bcr-Abl or its protein product),
but others are independent of Bcr-Abl. One
example of the latter is the overexpression of Src
kinases that has been reported in some patients
who develop resistance to imatinib. Thus, there is
considerable interest in developing more powerful
Bcr-Abl kinase inhibitors or dual Bcr-Abl and Src
kinase inhibitors, such as BMS-354825.
The results of initial trials of BMS-354825
in patients with CML resistant to imatinib are
extremely encouraging. The drug appears to
have an excellent toxicity profile with very few
extramedullary toxicities. The two phase III
clinical trials of BMS-354825 for patients with
CML in chronic, accelerated or blast phase, as well
as patients with Ph(+)ALL are currently open at
our center. The eligibility criteria are standard and
require failure on imatinib therapy (resistance or
toxicity).






Acute Myeloid Leukemia
1. Newly Diagnosed AML Non-M3
A. Decitabine induction vs. standard
induction (Age > 60)
B. Daunorubicin dose-intensification in
induction and autologous transplant
dose intensification +/- mylotarg in
consolidation (Age < 60)
2. Newly Diagnosed AML M3
A. Arsenic trioxide-based consolidation
therapy with state of the art
quantitative PCR for early prediction
and detection of relapse (Age 5-75)
3. Newly Diagnosed SECONDARY AML
A. Amonafide (novel topo-ll inhibitor) +
HiDAC for induction (Age >18)
4. AML in Remission
A. Tipifarnib (Farnesyl transferase inhibitor
R11577) in patients with at least CR2 or
CR1 after primary induction failure
(Age >18)
5. Salvage Therapy for AML
A. Cloretazine, a novel alkylating agent, in
combination with HiDAC for AML in 1st
relapse with a CR1 of > 3 months
(Age > 18)

Acute Lymphoblastic Leukemia
1. Newly Diagnosed ALL
A. Three-way comparison of
autologous transplant,
allogeneic transplant and conventional
consolidation/maintenance (Age 15-65)
2. Ph+ ALL
A. BMS-354825 for patients that are
resistant or intolerant to Gleevac
(Age > 18)
3. Relapsed/Refractory B-cell ALL
A. Open-label, repeat-dose study of




The UF Shands Cancer Center is proud to announce two
recent additions to its Web site: the Healthcare Professional
Section and the Clinical Trials Section.
The Healthcare Professional Section can be accessed directly,
at ufscc.ufl.edu/professional and includes information and
resources that will be especially helpful to those involved in
clinical care.
The Clinical Trials Section provides an interactive clinical
trial matching and referral service that is confidential and free
of charge. This service provides patients and physicians an
easy and efficient way of determining available trials that are
appropriate for enrollment. This service can also be accessed
calling 1-888-254-7581.


Foredesine HCI (BCX-1777) infusion
(Age > 18)
*opening Jan 2006
4. Relapsed T-cell ALL
A. Open-label, repeat-dose study of
Foredesine HCI (BCX-1777) infusion
(All ages)

Chronic Myelogenous Leukemia
1. Chronic Phase CML
A. BMS-354825 for CML patients that
are resistant or intolerant to Gleevec
(Age > 18)
2. Accelerated/Blast Phase CML
A. BMS-354825 for CML patients that
are resistant or intolerant to Gleevec
(Ages > 18)

Myelodysplastic Syndrome (MDS)
1. Low/Intermediate-1 Risk MDS
A. P38 MAP kinase inhibitor (Age > 18)

Multiple Myeloma
1. Newly Diagnosed MM
A. CC 5013 plus dexamethasone
(Age > 18)
B. Auto/auto +/- thal/dex
maintenance vs. auto/allo non-
myeloablative transplant
(Age < 70)

Lymphoma
1. Recurrent Follicular NHL
A. Auto vs. allo non-myeloablative
transplant (Age < 75)
2. Persistent/Relapsed Diffuse Large
B-cell NHL
A. Bexxar/BEAM vs. Rituxan/BEAM as
conditioning for autologous
transplant (Age 18-80)
3. Relapsed NHL
A. Bryostatin-1 plus Vincristine for
relapsed low or intermediate grade
NHL with relapse after stem cell
transplant (Age > 18)



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Th Link The Link is a publication of the
i10 LU nhI University of Florida Shands Cancer Center


Director
W. Stratford May, Jr., M.D., Ph.D.

Deputy Director
John R. Wingard, M.D.

Chief Administrative Officer
Joseph F. Woelkers, M.A.

Director, Marketing & PR
Diane K. Hammon, M.H.A.

Director, Clinical Trials Office
Robert D. Marsh, M.D.

Associate Director, Clinical Trials Office
Renee Boyette, B.S.N., O.C.N., C.C.R.C.

Contributors
Katarzyna Jamieson, M.D.
Joe Stokes, R.N.

Editor
Courtney P. Holmes

Design
Stephen Preston





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Shands Cancer Center
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