Trial Title:
A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)
NCT ID:
NCT06064097
Condition:
Stage II Nasopharyngeal Carcinoma AJCC v8
Stage III Nasopharyngeal Carcinoma AJCC v8
Stage IV Nasopharyngeal Carcinoma AJCC v8
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Cisplatin
Gemcitabine
Nivolumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo tissue biopsy
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood and stool sample collection
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Chest Radiography
Description:
Undergo chest x-ray
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
Chest X-ray
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Given IV
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
Abiplatin
Other name:
Blastolem
Other name:
Briplatin
Other name:
CDDP
Other name:
Cis-diammine-dichloroplatinum
Other name:
Cis-diamminedichloridoplatinum
Other name:
Cis-diamminedichloro Platinum (II)
Other name:
Cis-diamminedichloroplatinum
Other name:
Cis-dichloroammine Platinum (II)
Other name:
Cis-platinous Diamine Dichloride
Other name:
Cis-platinum
Other name:
Cis-platinum II
Other name:
Cis-platinum II Diamine Dichloride
Other name:
Cismaplat
Other name:
Cisplatina
Other name:
Cisplatinum
Other name:
Cisplatyl
Other name:
Citoplatino
Other name:
Citosin
Other name:
Cysplatyna
Other name:
DDP
Other name:
Lederplatin
Other name:
Metaplatin
Other name:
Neoplatin
Other name:
Peyrone's Chloride
Other name:
Peyrone's Salt
Other name:
Placis
Other name:
Plastistil
Other name:
Platamine
Other name:
Platiblastin
Other name:
Platiblastin-S
Other name:
Platinex
Other name:
Platinol
Other name:
Platinol- AQ
Other name:
Platinol-AQ
Other name:
Platinol-AQ VHA Plus
Other name:
Platinoxan
Other name:
Platinum
Other name:
Platinum Diamminodichloride
Other name:
Platiran
Other name:
Platistin
Other name:
Platosin
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Echocardiography
Description:
Undergo ECHO
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
EC
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Intervention type:
Other
Intervention name:
Fluciclovine F18
Description:
Given IV
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
(18F)Fluciclovine
Other name:
(18F)GE-148
Other name:
18F-Fluciclovine
Other name:
[18F]FACBC
Other name:
Anti-(18f)FABC
Other name:
Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid
Other name:
Anti-[18F] FACBC
Other name:
Axumin
Other name:
Fluciclovine (18F)
Other name:
FLUCICLOVINE F-18
Other name:
GE-148 (18F)
Other name:
GE-148 F-18
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Given IV
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
dFdC
Other name:
dFdCyd
Other name:
Difluorodeoxycytidine
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Multigated Acquisition Scan
Description:
Undergo MUGA
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
Blood Pool Scan
Other name:
Equilibrium Radionuclide Angiography
Other name:
Gated Blood Pool Imaging
Other name:
Gated Heart Pool Scan
Other name:
MUGA
Other name:
MUGA Scan
Other name:
Multi-Gated Acquisition Scan
Other name:
Radionuclide Ventriculogram Scan
Other name:
Radionuclide Ventriculography
Other name:
RNV Scan
Other name:
RNVG
Other name:
SYMA Scanning
Other name:
Synchronized Multigated Acquisition Scanning
Intervention type:
Biological
Intervention name:
Nivolumab
Description:
Given IV
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
ABP 206
Other name:
BCD-263
Other name:
BMS 936558
Other name:
BMS-936558
Other name:
BMS936558
Other name:
CMAB819
Other name:
MDX 1106
Other name:
MDX-1106
Other name:
MDX1106
Other name:
NIVO
Other name:
Nivolumab Biosimilar ABP 206
Other name:
Nivolumab Biosimilar BCD-263
Other name:
Nivolumab Biosimilar CMAB819
Other name:
ONO 4538
Other name:
ONO-4538
Other name:
ONO4538
Other name:
Opdivo
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
Quality of Life Assessment
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Intervention type:
Radiation
Intervention name:
Radiation Therapy
Description:
Receive radiation therapy
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
Cancer Radiotherapy
Other name:
Energy Type
Other name:
ENERGY_TYPE
Other name:
Irradiate
Other name:
Irradiated
Other name:
Irradiation
Other name:
Radiation
Other name:
Radiation Therapy, NOS
Other name:
Radiotherapeutics
Other name:
Radiotherapy
Other name:
RT
Other name:
Therapy, Radiation
Intervention type:
Procedure
Intervention name:
X-Ray Imaging
Description:
Undergo dental x-ray
Arm group label:
Treatment (nivolumab, gemcitabine, cisplatin, radiattion)
Other name:
Conventional X-Ray
Other name:
Diagnostic Radiology
Other name:
Medical Imaging, X-Ray
Other name:
Plain film radiographs
Other name:
Radiographic Imaging
Other name:
Radiographic imaging procedure (procedure)
Other name:
Radiography
Other name:
RG
Other name:
Static X-Ray
Other name:
X-Ray
Summary:
This phase II trial tests effects of nivolumab in combination with chemotherapy drugs
prior to radiation therapy patients with nasopharyngeal carcinoma (NPC). Immunotherapy
with monoclonal antibodies, such as nivolumab, may help the body's immune system attack
the cancer, and may interfere with the ability of tumor cells to grow and spread.
Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the
growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or
radioactive seeds to kill cancer cells and shrink tumors. Researchers want to find out
what effects, good and/or bad, adding nivolumab to chemotherapy has on patients with
newly diagnosed NPC. In addition, they want to find out if children with NPC may be
treated with less radiation therapy and whether this decreases the side effects of
therapy.
Detailed description:
PRIMARY OBJECTIVE:
I. To evaluate safety of combining chemotherapy (cisplatin and gemcitabine) with an
anti-PD1 immune checkpoint inhibitor (nivolumab) in children, adolescents and young
adults with nasopharyngeal carcinoma (NPC) by determining the rate of Common Terminology
Criteria for Adverse Events (CTCAE) grade 3 or higher immune related adverse events
(irAEs).
SECONDARY OBJECTIVES:
I. To estimate the 2-year event-free survival (EFS) of children, adolescents and young
adults with NPC who are treated with induction chemoimmunotherapy (CIT), followed by
consolidation chemoradioimmunotherapy (CRIT, cisplatin, nivolumab and response-adjusted,
dose de-escalated radiation therapy), and nivolumab maintenance therapy.
II. To evaluate the objective response rate (ORR) including complete responders and
partial responders (complete response [CR] + partial response [PR]) of neoadjuvant CIT.
III. To evaluate feasibility of combining chemotherapy (cisplatin and gemcitabine) with
an anti-PD1 immune checkpoint inhibitor (nivolumab) in children, adolescents and young
adults with nasopharyngeal carcinoma (NPC).
IV. To evaluate the cumulative incidence of local and distant relapse.
EXPLORATORY OBJECTIVES:
I. To estimate 5-year EFS and overall survival (OS) of children with NPC who are treated
with induction CIT followed by consolidation CRIT, and nivolumab maintenance therapy.
II. To compare response assessed by fludeoxyglucose F18 (FDG) positron emission
tomography (PET) versus magnetic resonance imaging (MRI).
III. To determine treatment outcomes for patients treated with radiation per protocol
versus (vs) deviation.
IV. To evaluate outcomes comparing patients receiving intensity modulated radiation
therapy (IMRT) to proton therapy.
V. To objectively measure both acute and long-term toxicity including immune related
adverse events and radiation late effects.
VI. To evaluate swallowing dysfunction using patient reported outcome (PRO) measures for
children and adults throughout the protocol for up to 5 years.
VII. To evaluate quality of life (QOL) using Patient-Reported Outcomes Measurement
Information System (PROMIS) multidimensional questionnaire throughout the protocol for up
to 5 years.
VIII. To correlate the lymphocyte to monocyte ratio on complete blood counts (CBCs) with
treatment response and outcomes.
IX. To collect and bank specimens (including tumor, blood and stool) for future research
studies.
OUTLINE:
INDUCTION THERAPY: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1
of each cycle, gemcitabine IV over 30 minutes on days 1 and 8 of each cycle, and
cisplatin IV over 3-6 hours on day 1 of each cycle. Treatment repeats every 21 days for 3
cycles in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients receive nivolumab IV over 30 minutes on day 1 of each
cycle and cisplatin IV over 3-6 hours on day 1 of cycles 1-2. Treatment repeats every 21
days for 3 cycles in the absence of disease progression or unacceptable toxicity.
Patients also receive concurrent radiation therapy on trial.
MAINTENANCE THERAPY: Patients receive nivolumab IV over 30 minutes on day 1 of each
cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression
or unacceptable toxicity.
Patients also undergo echocardiography (ECHO) or multigated acquisition scan (MUGA)
during screening and as clinically indicated on trial. Patients undergo MRI, FDG PET, and
computed tomography (CT) throughout the trial and chest x-ray during follow-up. Patients
also undergo dental x-ray imaging on the trial. Patients may optionally undergo tissue
biopsy, blood and stool sample collection during screening and on trial.
After completion of study treatment, patients are followed up every 3 months for 12
months, every 6 months until 24 months off therapy, and then yearly until 5 years off
therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must be ≤ 21 years of age at the time of study enrollment
- Newly diagnosed American Joint Committee on Cancer (AJCC) stage II-IV nasopharyngeal
carcinoma (NPC)
- Patients must have had histologic verification of the malignancy at original
diagnosis
- Although submission of tumor tissue for the molecular characterization
initiative is not required for eligibility, it is strongly recommended
- Patients must have had histologic verification of the malignancy at original
diagnosis
- Although submission of tumor tissue for the molecular characterization initiative is
not required for eligibility, it is strongly recommended
- Patients must have a Lansky (for patients ≤ 16 years of age) or Karnofsky (for
patients > 16 years of age) performance status score of ≥ 60%
- Peripheral absolute neutrophil count (ANC) ≥ 1000/uL (within 7 days prior to start
of protocol therapy)
- Platelet count ≥ 100,000/uL (transfusion independent) (within 7 days prior to start
of protocol therapy)
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60
mL/min/1.73 m^2 or (within 7 days prior to start of protocol therapy)
- A serum creatinine based on age/gender (within 7 days prior to start of protocol
therapy) Age: Maximum serum creatinine (mg/dL)
1 month to < 6 months: 0.4 mg/dL (male); 0.4 mg/dL (female) 6 months to < 1 year:
0.5 mg/dL (male); 0.5 mg/dL (female)
1 to < 2 years: 0.6 mg/dL (male); 0.6 mg/dL (female) 2 to < 6 years: 0.8 mg/dL
(male); 0.8 mg/dL (female) 6 to < 10 years 1 mg/dL (male); 1 mg/dL (female) 10 to
<13 years: 1.2 mg/dL (male); 1.2 mg/dL (female) 13 to < 16 years: 1.5 mg/dL (male);
1.4 mg/dL (female)
≥ 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and (within 7 days
prior to start of protocol therapy)
- Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) ≤ 135
U/L* (within 7 days prior to start of protocol therapy)
- Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the
value of 45 U/L
- Shortening fraction of ≥ 27% by echocardiogram, or
- Ejection fraction of ≥ 50% by radionuclide angiogram
- No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94%
if there is clinical indication for determination
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months and T-cell count above the
lower limit of normal are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV
viral load must be undetectable on suppressive therapy, if indicated. Patients with
a history of hepatitis C virus (HCV) infection must have been treated and cured. For
patients with HCV infection who are currently on treatment, they are eligible if
they have an undetectable HCV viral load
Exclusion Criteria:
- Patients who received prior radiotherapy to the head or neck
- Patients who received prior chemotherapy or radiation for the treatment of any
cancer in the last 3 years. These patients must also be in remission
- Patients with a diagnosis of immunodeficiency
- Patients with an active autoimmune disease that has required systemic treatment in
the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or
immunosuppressive agents). Replacement therapy (e.g., thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency, etc.) is not considered a form of systemic treatment.
- Note: Patients with well-controlled asthma and no need for systemic steroids
for the treatment of asthma in the last 12 months will not be excluded
- Patients with a condition requiring systemic treatment with either corticosteroids
(> 0.25 mg/kg (10 mg) daily prednisone equivalent) within 14 days or other
immunosuppressive medications within 30 days of enrollment. Inhaled or topical
steroids, and adrenal replacement steroid doses > 0.25 mg/kg (10 mg) daily
prednisone equivalent, are permitted in the absence of active autoimmune disease
- Patients with a history of (non-infectious) pneumonitis that required steroids or
current pneumonitis
- Patients with detectable viral load of human immunodeficiency virus (HIV), hepatitis
B or hepatitis C, or active tuberculosis
- Patients who have undergone solid organ or allogeneic hematopoietic transplant at
any time
- Due to risks of fetal and teratogenic adverse events as seen in animal studies, a
negative pregnancy test must be obtained in females of childbearing potential,
defined as females who are post-menarchal. If the urine test is positive or cannot
be confirmed as negative, a serum pregnancy test will be required
- Females of childbearing potential that are sexually active must agree to either
practice 2 medically accepted highly-effective methods of contraception at the same
time or abstain from heterosexual intercourse from the time of signing the informed
consent through 5 months after the last dose of nivolumab, 6 months after the last
dose of gemcitabine, and 14 months after the last dose of cisplatin, whichever is
longer
- Males of childbearing potential that are sexually active must agree to either
practice a medically accepted highly-effective methods of contraception or abstain
from heterosexual intercourse from the time of signing the informed consent through
3 months after the last dose of gemcitabine, and 11 months after the last dose of
cisplatin, whichever is longer
- Lactating females are not eligible unless they have agreed not to breastfeed their
infants starting with the first dose of study therapy through 5 months after the
last dose of nivolumab
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
Gender:
All
Minimum age:
N/A
Maximum age:
21 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Children's Hospital of Alabama
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
205-638-9285
Email:
oncologyresearch@peds.uab.edu
Investigator:
Last name:
Jamie M. Aye
Email:
Principal Investigator
Facility:
Name:
Arkansas Children's Hospital
Address:
City:
Little Rock
Zip:
72202-3591
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
501-364-7373
Investigator:
Last name:
David L. Becton
Email:
Principal Investigator
Facility:
Name:
Kaiser Permanente Downey Medical Center
Address:
City:
Downey
Zip:
90242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
626-564-3455
Investigator:
Last name:
Robert M. Cooper
Email:
Principal Investigator
Facility:
Name:
UCSF Benioff Children's Hospital Oakland
Address:
City:
Oakland
Zip:
94609
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
510-428-3264
Email:
cogbchoak@ucsf.edu
Investigator:
Last name:
Jennifer G. Michlitsch
Email:
Principal Investigator
Facility:
Name:
Kaiser Permanente-Oakland
Address:
City:
Oakland
Zip:
94611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-642-4691
Email:
Kpoct@kp.org
Investigator:
Last name:
Aarati V. Rao
Email:
Principal Investigator
Facility:
Name:
Alfred I duPont Hospital for Children
Address:
City:
Wilmington
Zip:
19803
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-651-5572
Email:
Allison.bruce@nemours.org
Investigator:
Last name:
Scott M. Bradfield
Email:
Principal Investigator
Facility:
Name:
Children's National Medical Center
Address:
City:
Washington
Zip:
20010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
202-476-2800
Email:
OncCRC_OnCall@childrensnational.org
Investigator:
Last name:
Jeffrey S. Dome
Email:
Principal Investigator
Facility:
Name:
University of Florida Health Science Center - Gainesville
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
352-273-8010
Email:
cancer-center@ufl.edu
Investigator:
Last name:
Brian Stover
Email:
Principal Investigator
Facility:
Name:
Nemours Children's Clinic-Jacksonville
Address:
City:
Jacksonville
Zip:
32207
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-651-5572
Email:
Allison.bruce@nemours.org
Investigator:
Last name:
Scott M. Bradfield
Email:
Principal Investigator
Facility:
Name:
Nicklaus Children's Hospital
Address:
City:
Miami
Zip:
33155
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-624-2778
Investigator:
Last name:
Maggie E. Fader
Email:
Principal Investigator
Facility:
Name:
Nemours Children's Hospital
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-651-5572
Email:
Allison.bruce@nemours.org
Investigator:
Last name:
Scott M. Bradfield
Email:
Principal Investigator
Facility:
Name:
Riley Hospital for Children
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-248-1199
Investigator:
Last name:
Marissa Just
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins University/Sidney Kimmel Cancer Center
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
410-955-8804
Email:
jhcccro@jhmi.edu
Investigator:
Last name:
Robyn D. Gartrell
Email:
Principal Investigator
Facility:
Name:
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-267-1925
Email:
crcwm-regulatory@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
855-776-0015
Investigator:
Last name:
Peter Schoettler
Email:
Principal Investigator
Facility:
Name:
University of Mississippi Medical Center
Address:
City:
Jackson
Zip:
39216
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
601-815-6700
Investigator:
Last name:
Betty L. Herrington
Email:
Principal Investigator
Facility:
Name:
Children's Mercy Hospitals and Clinics
Address:
City:
Kansas City
Zip:
64108
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
816-302-6808
Email:
rryan@cmh.edu
Investigator:
Last name:
Keith J. August
Email:
Principal Investigator
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Frederick S. Huang
Email:
Principal Investigator
Facility:
Name:
Children's Hospital and Medical Center of Omaha
Address:
City:
Omaha
Zip:
68114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
402-955-3949
Investigator:
Last name:
Jill C. Beck
Email:
Principal Investigator
Facility:
Name:
University of Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
402-559-6941
Email:
unmcrsa@unmc.edu
Investigator:
Last name:
Jill C. Beck
Email:
Principal Investigator
Facility:
Name:
Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
551-996-2897
Investigator:
Last name:
Katharine Offer
Email:
Principal Investigator
Facility:
Name:
Newark Beth Israel Medical Center
Address:
City:
Newark
Zip:
07112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
973-926-7230
Email:
Christine.Kosmides@rwjbh.org
Investigator:
Last name:
Teena Bhatla
Email:
Principal Investigator
Facility:
Name:
Albany Medical Center
Address:
City:
Albany
Zip:
12208
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
518-262-5513
Investigator:
Last name:
Lauren R. Weintraub
Email:
Principal Investigator
Facility:
Name:
Rainbow Babies and Childrens Hospital
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
216-844-5437
Investigator:
Last name:
Duncan S. Stearns
Email:
Principal Investigator
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
405-271-8777
Email:
ou-clinical-trials@ouhsc.edu
Investigator:
Last name:
Rene Y. McNall-Knapp
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
267-425-5544
Email:
CancerTrials@email.chop.edu
Investigator:
Last name:
Theodore W. Laetsch
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Pittsburgh of UPMC
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
412-692-8570
Email:
jean.tersak@chp.edu
Investigator:
Last name:
Brittani K. Seynnaeve
Email:
Principal Investigator
Facility:
Name:
Prisma Health Richland Hospital
Address:
City:
Columbia
Zip:
29203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
864-241-6251
Investigator:
Last name:
Stuart L. Cramer
Email:
Principal Investigator
Facility:
Name:
Saint Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-226-4343
Email:
referralinfo@stjude.org
Investigator:
Last name:
Catherine G. Lam
Email:
Principal Investigator
Facility:
Name:
Vanderbilt University/Ingram Cancer Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-811-8480
Investigator:
Last name:
Scott C. Borinstein
Email:
Principal Investigator
Facility:
Name:
Dell Children's Medical Center of Central Texas
Address:
City:
Austin
Zip:
78723
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
512-628-1902
Email:
TXAUS-DL-SFCHemonc.research@ascension.org
Investigator:
Last name:
Shannon M. Cohn
Email:
Principal Investigator
Facility:
Name:
UT Southwestern/Simmons Cancer Center-Dallas
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
214-648-7097
Email:
canceranswerline@UTSouthwestern.edu
Investigator:
Last name:
Avanthi T. Shah
Email:
Principal Investigator
Facility:
Name:
Cook Children's Medical Center
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
682-885-2103
Email:
CookChildrensResearch@cookchildrens.org
Investigator:
Last name:
Chelsee Greer
Email:
Principal Investigator
Facility:
Name:
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
713-798-1354
Email:
burton@bcm.edu
Investigator:
Last name:
Mehmet F. Okcu
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of San Antonio
Address:
City:
San Antonio
Zip:
78207
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
210-704-2894
Email:
bridget.medina@christushealth.org
Investigator:
Last name:
Julie Voeller
Email:
Principal Investigator
Facility:
Name:
University of Virginia Cancer Center
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
434-243-6303
Email:
uvacancertrials@hscmail.mcc.virginia.edu
Investigator:
Last name:
Brian C. Belyea
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of The King's Daughters
Address:
City:
Norfolk
Zip:
23507
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
757-668-7243
Email:
CCBDCresearch@chkd.org
Investigator:
Last name:
Eric J. Lowe
Email:
Principal Investigator
Facility:
Name:
Seattle Children's Hospital
Address:
City:
Seattle
Zip:
98105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
866-987-2000
Investigator:
Last name:
Sarah E. Leary
Email:
Principal Investigator
Facility:
Name:
Mary Bridge Children's Hospital and Health Center
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
253-403-1461
Email:
research@multicare.org
Investigator:
Last name:
Robert G. Irwin
Email:
Principal Investigator
Start date:
June 25, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06064097
