Tentative Protocols for the Upcoming Year - 2012
Dept
Mnemonic
Type
PI
Description
Number of Sites
Solid Tumor
GD2NK
Prospective,
Therapeutic,
Phase I
Prospective,
Therapeutic
Prospective,
Therapeutic
Prospective,
Therapeutic,
Phase I/II
Prospective,
Therapeutic,
Phase I
Prospective,
Therapeutic,
Phase I
Furman
St. Jude only
Furman
IND and IDE, Phase I Relapsed/refractory
neuroblastoma with GD2 antibody and NK
cells. Investigator-initiated
Newly diagnosed Ewings and desmoid small
round cell tumors
Newly diagnosed high risk neuroblastoma
McGregor
ridaforolimus (m-TOR inhibitor)
McGregor
Dalotuzumab (IGF-IR inhibitor) monotherapy
phase I, and then phase II
ridaforolimus/dalotuzumab combination
Zelboraf – pts with relapsed/refractory
melanoma with BRAF mutations
Prospective,
Therapeutic,
Phase I
Phase I
Prospective,
Therapeutic,
Phase III
TBD*
Sponsored by
Merck. St. Jude is a
site
Sponsored by
Merck. St. Jude is a
site
Sponsored by
HoffmanLaRoche/Genentech.
St. Jude is a site
Sponsored by
United Therapeutics
Prospective,
Therapeutic,
Phase II
Prospective,
Therapeutic,
Phase II
Bhojwani
EFST12
NB2012
MKRIDA
MKDALO
MELPLX
TBD*
Brain Tumor
SJREFU
SJMB12
Leukemia /
Lymphoma
ALLR18
HODHR12
Prepared by E. Hampton
Jan. 24, 2012
Navid
Navid
Wright
Gajjar
Metzger
A new ch14.18 (IL-2, cis-retinoic) – ch14.18
antibody for neuroblastoma after transplant –
maintenance
Relasped/refractory ependymoma
It will basically be SJMB03 therapy with the
new GDC-0449 added up front. Same
collaborators as SJMB03
NK Cell transfusion (IDE). Consent,
enrollment, induction must be done at St. Jude
for all participating sites.
Newly diagnosed phase II high risk HD. Will
submit IND application, FDA may or may not
exempt. Seattle Genetics will supply SGN-35,
which will be given in combination with
Stanford V chemotherapy.
St. Jude only
St Jude only
St. Jude only
SJ, Brisbane,
CHOP, Duke,
Melbourne, Sydney,
TX Children,
Toronto, Westmead
SJ, Rady
St. Jude only
Dept
Mnemonic
Type
PI
Description
Number of Sites
Leukemia /
Lymphoma
RET6
Prospective,
Therapeutic
Brennan
Newly diagnosed intra-ocular retinoblastoma.
Primary objective is biologic, but will enroll
all patient all stages with intraocular
retinoblastoma presenting to St. Jude.
St. Jude only
ALL1121
Prospective,
Therapeutic
Bhojwani
BiTE study
COG, but industry
sponsored and
monitored
RESPV2
Prospective,
Non-Therapeutic
Srinivasan
A prospective 2 year study for viral load
determination of adenovirus, rhinovirus, RSV,
parainfluenza, influenza and CMV in NP
wash samples from allogeneic HSCT patients
with symptomatic URTI and/or LRTI. We
propose to start this off at St Jude expecting to
accrue 100 patients over 2 years (based on
RESPVI numbers), and hopefully include 2
other BMT sites including adult centers, for a
total expected accrual of about 300-400
patients and 1000 samples.
UCBT with ex vivo expanded NK cells for
hematologic malignancies.
Feasibility pilot study to examine the
acceptability of and initial response to growth
hormone replacement therapy for survivors of
childhood leukemia who were treated with
cranial radiation and who have adult growth
hormone deficiency and poor quality of life.
In this pilot study, participants will be
randomized to receive either growth hormone
replacement or placebo for the 15 month trial.
2 Pharma/Industry
1 PHACS network
2 SJ Investigator
3 ATN network
3 IMPAACT network
St. Jude and 2 sites
TGT
UCBNK
Epidemiology
GROWTH
Infectious
Diseases
Prepared by E. Hampton
Jan. 24, 2012
Dallas
Pilot
Chemaitilly
St. Jude only
St. Jude only
St. Jude is a site
St. Jude is a site
St. Jude only
St. Jude is a site
St. Jude is a site
Dept
Mnemonic
Type
PI
Description
Number of Sites
Psychology
MEMFX3
Prospective
Conklin
Genetic Polymorphisms as predictors of
response to MPH on MEMFX2
DC-TRN
(grant:
ACCL10P1)
CSqHPV
Prospective
Conklin
Prophylactic CogMed training during RT
Likely SJ only, but
MEMFX2 also
included Duke and
Med. Univ. S.
Carolina (possibly)
SJ is one of 8
participating sites
Prospective,
therapeutic
Klosky
ACYSCD
Prospective, nontherapeutic
Porter
Enuresis and
Pica in Sickle
Cell Disease
Prospective, nontherapeutic
Porter
BMTPE3
Prospective, nontherapeutic
Phipps
SMTEXT
Prospective, nontherapeutic
Tyc
Quadrivalent Human Papillomavirus (qHPV)
Vaccine in Cancer Survivors: Cross Sectional
Survey and Phase II Open-Label Vaccine
Trial
This study entails 6 focus groups of
adolescents with Sickle Cell Disease, their
caregivers, and young adults ages 18-25 who
have transitioned to adult providers. We will
be identifying their perceptions about
transition, transition readiness, current disease
management skills, and perceptions of the
components of the current transition program.
Patients with SCD ages 6-18 and caregivers
will complete questionnaires about enuresis
and pica behaviors and interventions utilized,
in addition to measures of family stress,
treatment acceptability, emotional
functioning. Medical information from
MILLI will be gathered.
Cognitive, Academic And Psychosocial
Functioning In Long-Term Survivors Of
Pediatric Stem Cell Transplantation
The Feasibility Of Text Messaging To Assess
Secondhand Smoke Exposure Among
Youngsters With Cancer And Sickle Cell
Disease
Psychology
Prepared by E. Hampton
Jan. 24, 2012
This is a Consortium
for Pediatric
Interventional
Research study
SJ only
SJ only
SJ only
SJ only
Dept
Psychology
Mnemonic
SMOBAN
Type
Prospective, nontherapeutic
PI
Tyc
Hematology
TBD*
Prospective,
therapeutic
Nienhuis
SRVIRON
Prospective, nontherapeutic
Nottage
TBD*
Prospective, nontherapeutic
Nottage
TBD* - To be determined
Prepared by E. Hampton
Jan. 24, 2012
Description
Number of Sites
An assessment of preferences for smoking ban SJ only
vs. smoking cessation interventions among
families of children with cancer and sickle
cell disease
An open label dose-escalation study of a self- SJ Only
complementary adeno-associated viral vector
for gene transfer in subjects with
Galactosialidosis” during the next 12 -18
months.
A cross-sectional, non-therapeutic study of
iron overload in long-term cancer survivors.
This will be in conjunction with the Epi
department and will involve clinical
evaluation, blood tests, Echos, and MRI in
cancer survivors.
Longitudinal cohort in sickle cell disease:
non-therapeutic cohort study of patients at
SJCRH (pediatric) and Methodist (adult
patients) with sickle cell disease. The aim
will be to establish a long-term cohort and
collect clinical data on which to base further
research. Similar to SJLIFE.
SJ Only
SJ and Methodist
Dept
Hematology
Mnemonic
TBD*
Type
Prospective, nontherapeutic
PI
Nottage
Description
Translational Study of the Efficacy of Novel
Compounds in Erythrocytes Affected by
Pyruvate Kinase Deficiency or Chronic
Hemolytic Processes: The primary aim of
this study is to explore the activity of several
novel compounds currently in development
at Agios Pharmaceuticals in purified
erythrocytes from patients with PKDassociated or other chronic hemolytic
anemia’s. Non-therapeutic, one time blood
draws.
Number of Sites
SJ only
SICHA
Prospective, nontherapeutic
Nottage
Splenectomy in Congenital Hemolytic
Anemia): The aim of the study is to record in
a internet-accessible disease registry relevant
clinical outcomes of children with congenital
hemolytic anemias who are undergoing total
or partial splenectomy. Outcomes will
include clinical events, hematologic results,
perioperative outcomes, imaging data, and
adverse events. No specific surgical
procedure, medical tests, or therapies will be
mandated by this study.
SJ only
EPIC
Prospective,
therapeutic
Estepp
Intravenous Enoxaparin in Pediatric
Thromboembolism: A Dose Finding and
Pharmacodynamics Study (EPIC). Determine
a dosage (mg/kg/dose) of enoxaparin
administered intravenously that provides
therapeutic peak anti-Xa levels without
excessive clinical toxicity.
SJ only
HUG3
Prospective,
therapeutic
Wing
Protocol design similar to HUG2
SJ only
Prepared by E. Hampton
Jan. 24, 2012