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Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT01979536
Recruitment Status : Recruiting
First Posted : November 8, 2013
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib and combination chemotherapy works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Crizotinib and methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether brentuximab vedotin and combination chemotherapy is more effective than crizotinib and combination chemotherapy in treating anaplastic large cell lymphoma.

Condition or disease Intervention/treatment Phase
Anaplastic Large Cell Lymphoma, ALK-Positive Ann Arbor Stage II Noncutaneous Childhood Anaplastic Large Cell Lymphoma Ann Arbor Stage III Noncutaneous Childhood Anaplastic Large Cell Lymphoma Ann Arbor Stage IV Noncutaneous Childhood Anaplastic Large Cell Lymphoma CD30-Positive Neoplastic Cells Present Drug: Brentuximab Vedotin Drug: Crizotinib Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone Drug: Doxorubicin Hydrochloride Drug: Etoposide Drug: Ifosfamide Other: Laboratory Biomarker Analysis Drug: Methotrexate Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the tolerability of brentuximab vedotin given in combination with standard chemotherapy (anaplastic large cell lymphoma [ALCL]99) and to determine the tolerability of crizotinib given in combination with chemotherapy (ALCL99).

II. To estimate the event free survival (EFS) of Arm brentuximab vedotin (BV) and Arm crizotinib (CZ) and contrast these to historical control data.

SECONDARY OBJECTIVES:

I. To determine the prognostic significance of minimal disseminated disease (MDD) at diagnosis and minimal residual disease (MRD) as measured by real-time (RT)-polymerase chain reaction (PCR) in peripheral blood.

OUTLINE: Patients are assigned or randomized into 1 of 2 treatment arms.

ARM BV:

COURSE A (COURSES 1, 3, AND 5): Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1, dexamethasone orally (PO) twice daily (BID) or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5.

COURSE B (COURSES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5.

ARM CZ:

COURSE A (COURSES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A.

COURSE B (COURSES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.

In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Trial of Brentuximab Vedotin (SGN35, NSC# 749710), or Crizotinib (NSC#749005, Commercially Labeled) in Combination With Chemotherapy for Newly Diagnosed Patients With Anaplastic Large Cell Lymphoma (ALCL)
Actual Study Start Date : November 8, 2013
Estimated Primary Completion Date : September 30, 2020


Arm Intervention/treatment
Experimental: Arm BV (brentuximab vedotin, combination chemotherapy)

COURSE A (COURSES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5.

COURSE B (COURSES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5.

Drug: Brentuximab Vedotin
Given IV
Other Names:
  • ADC SGN-35
  • Adcetris
  • Anti-CD30 Antibody-Drug Conjugate SGN-35
  • Anti-CD30 Monoclonal Antibody-MMAE SGN-35
  • Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35
  • cAC10-vcMMAE
  • SGN-35

Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719

Drug: Cytarabine
Given IT and IV
Other Names:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-Beta-D-arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-cell
  • Arabine
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytin
  • Aracytine
  • Beta-cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-beta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453

Drug: Dexamethasone
Given PO or IV
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone

Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16-213
  • VP-16
  • VP-16-213

Drug: Ifosfamide
Given IV
Other Names:
  • Asta Z 4942
  • Asta Z-4942
  • Cyfos
  • Holoxan
  • Holoxane
  • Ifex
  • IFO
  • IFO-Cell
  • Ifolem
  • Ifomida
  • Ifomide
  • Ifosfamidum
  • Ifoxan
  • IFX
  • Iphosphamid
  • Iphosphamide
  • Iso-Endoxan
  • Isoendoxan
  • Isophosphamide
  • Mitoxana
  • MJF 9325
  • MJF-9325
  • Naxamide
  • Seromida
  • Tronoxal
  • Z 4942
  • Z-4942

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Methotrexate
Given IT and IV
Other Names:
  • Abitrexate
  • Alpha-Methopterin
  • Amethopterin
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex
  • Folex PFS
  • Lantarel
  • Ledertrexate
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Methoblastin
  • Methotrexate LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate
  • Mexate-AQ
  • MTX
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039

Experimental: Arm CZ (crizotinib, combination chemotherapy)

COURSE A (COURSES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A.

COURSE B (COURSES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.

Drug: Crizotinib
Given PO
Other Names:
  • MET Tyrosine Kinase Inhibitor PF-02341066
  • PF-02341066
  • PF-2341066
  • Xalkori

Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719

Drug: Cytarabine
Given IT and IV
Other Names:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-Beta-D-arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-cell
  • Arabine
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytin
  • Aracytine
  • Beta-cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-beta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453

Drug: Dexamethasone
Given PO or IV
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone

Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16-213
  • VP-16
  • VP-16-213

Drug: Ifosfamide
Given IV
Other Names:
  • Asta Z 4942
  • Asta Z-4942
  • Cyfos
  • Holoxan
  • Holoxane
  • Ifex
  • IFO
  • IFO-Cell
  • Ifolem
  • Ifomida
  • Ifomide
  • Ifosfamidum
  • Ifoxan
  • IFX
  • Iphosphamid
  • Iphosphamide
  • Iso-Endoxan
  • Isoendoxan
  • Isophosphamide
  • Mitoxana
  • MJF 9325
  • MJF-9325
  • Naxamide
  • Seromida
  • Tronoxal
  • Z 4942
  • Z-4942

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Methotrexate
Given IT and IV
Other Names:
  • Abitrexate
  • Alpha-Methopterin
  • Amethopterin
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex
  • Folex PFS
  • Lantarel
  • Ledertrexate
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Methoblastin
  • Methotrexate LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate
  • Mexate-AQ
  • MTX
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039




Primary Outcome Measures :
  1. Occurrence of grade 3+ non-hematologic adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: Up to 60 months ]
    Toxicities will be summarized by individual toxicity counts and incidence rate separated by arm and course.

  2. Event free survival (EFS) [ Time Frame: Time from study entry until progressive disease, relapse, or death, assessed up to 60 months ]
    The EFS for each of the treatment regimens will be compared to the fixed standard using Woolson's 1-sample log-rank test.


Secondary Outcome Measures :
  1. Changes on levels of minimal residual disease [ Time Frame: Baseline up to day 21 (course 1) ]
    Analyzed using the log-rank test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed patients with histologically proven ALCL (International Classification of Diseases for Oncology [ICD-0] code: 9714/3)
  • Disease must be cluster of differentiation (CD)30 positive
  • Disease must be anaplastic lymphoma kinase (ALK) positive (defined by local institutional standards)
  • Patients must have stage II, III, or IV disease
  • Patients must have a life expectancy of >= 8 weeks
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x upper limit of normal (ULN) for age; for the purpose of this study, the ULN for ALT is 45 U/L
  • If the lab abnormality is thought to be due to the lymphoma the patient is eligible and dose adjustments should be made
  • Shortening fraction of >= 27% by echocardiogram, or
  • Ejection fraction of >= 50% by radionuclide angiogram
  • Patients with a history of pulmonary dysfunction must have no evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry > 92% while breathing room air unless current dysfunction is due to the lymphoma in which case the patient is eligible

Exclusion Criteria:

  • Patients with central nervous system (CNS) disease are not eligible
  • Patients with disease limited to the skin are not eligible, regardless of how wide-spread
  • Patients with stage I disease are not eligible
  • Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of ALCL or any cancer diagnosed previously are not eligible
  • Previous steroid treatment and/or radiation treatment is not allowed unless it is for the emergent management of a mediastinal mass; emergent steroid treatment and/or radiation treatment should stop once protocol therapy is initiated
  • Intrathecal chemotherapy prior to enrollment is allowed for the current diagnosis of ALCL as long as adequate cerebrospinal fluid (CSF) is obtained prior to administration of the intrathecal chemotherapy and subsequently demonstrated to be negative for ALCL
  • Female patients who are pregnant are not eligible; pregnancy tests must be obtained in girls who are post menarchal
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants
  • Sexually active patients of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of treatment and for 3 months after stopping treatment
  • Patients with Down syndrome are not eligible
  • Patients with an immunodeficiency that existed prior to diagnosis such as primary immunodeficiency syndromes or organ transplant recipients are not eligible
  • Cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) substrates with narrow therapeutic indices: Patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices including pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; the topical use of these medications (if applicable) is allowed
  • CYP3A4 inhibitors: patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to ketoconazole, itraconazole, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, delavirdine, nefazodone, diltiazem, verapamil, and grapefruit juice are not eligible; the topical use of these medications (if applicable), e.g. 2% ketoconazole cream, is allowed
  • CYP3A4 inducers: patients chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, ritonavir, and St. John's wort are not eligible; the topical use of these medications (if applicable) is allowed
  • Patients that are known to be positive for human immunodeficiency virus (HIV) are not eligible; note: inclusion of HIV positive patients will be considered at a later date
  • Patients who weigh < 10 kg are not eligible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979536


  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Matthew A. Kutny         
United States, Arizona
Phoenix Childrens Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Site Public Contact    602-546-0920      
Principal Investigator: Jessica Boklan         
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: David L. Becton         
United States, California
Kaiser Permanente Downey Medical Center Recruiting
Downey, California, United States, 90242
Contact: Site Public Contact    626-564-3455      
Principal Investigator: Robert M. Cooper         
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Site Public Contact    800-826-4673    becomingapatient@coh.org   
Principal Investigator: Anna B. Pawlowska         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Site Public Contact    909-558-3375      
Principal Investigator: Albert Kheradpour         
Miller Children's and Women's Hospital Long Beach Recruiting
Long Beach, California, United States, 90806
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Pamela H. Kempert         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Leo Mascarenhas         
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Site Public Contact    310-423-8965      
Principal Investigator: Fataneh (Fae) Majlessipour         
Valley Children's Hospital Recruiting
Madera, California, United States, 93636
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Vonda L. Crouse         
Children's Hospital and Research Center at Oakland Recruiting
Oakland, California, United States, 94609-1809
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Carla B. Golden         
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Elyssa M. Rubin         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Sheri L. Spunt         
Sutter Medical Center Sacramento Recruiting
Sacramento, California, United States, 95816
Contact: Site Public Contact    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Yung S. Yim         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Site Public Contact    916-734-3089      
Principal Investigator: Marcio H. Malogolowkin         
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: William D. Roberts         
Naval Medical Center -San Diego Recruiting
San Diego, California, United States, 92134
Contact: Site Public Contact    619-532-8712      
Principal Investigator: Shelton A. Viola         
UCSF Medical Center-Parnassus Active, not recruiting
San Francisco, California, United States, 94143
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Site Public Contact    877-827-3222      
Principal Investigator: Michelle L. Hermiston         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Kelly W. Maloney         
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jennifer J. Clark         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Michael S. Isakoff         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Site Public Contact    203-785-5702    canceranswers@yale.edu   
Principal Investigator: Nina S. Kadan-Lottick         
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Site Public Contact    302-651-6884    dperry@nemours.org   
Principal Investigator: Emi H. Caywood         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jeffrey S. Dome         
United States, Florida
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Emad K. Salman         
University of Florida Health Science Center - Gainesville Suspended
Gainesville, Florida, United States, 32610
Nemours Children's Clinic-Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Emi H. Caywood         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Site Public Contact    305-243-2647      
Principal Investigator: Julio C. Barredo         
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Enrique A. Escalon         
Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Site Public Contact    407-303-2090    FH.Cancer.Research@flhosp.org   
Principal Investigator: Fouad M. Hajjar         
Arnold Palmer Hospital for Children Recruiting
Orlando, Florida, United States, 32806
Contact: Site Public Contact    321-843-2584    melissa.leffin@orlandohealth.com   
Principal Investigator: Don E. Eslin         
UF Cancer Center at Orlando Health Active, not recruiting
Orlando, Florida, United States, 32806
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Emi H. Caywood         
Nemours Children's Clinic - Pensacola Suspended
Pensacola, Florida, United States, 32504
Johns Hopkins All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nanette H. Grana         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Site Public Contact    813-844-7829    syapchanyk@tgh.org   
Principal Investigator: Juan F. Rico         
Saint Joseph's Hospital/Children's Hospital-Tampa Recruiting
Tampa, Florida, United States, 33607
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mark J. Mogul         
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Melinda G. Pauly         
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: Site Public Contact    912-350-7887    clayter1@memorialhealth.com   
Principal Investigator: Andrew L. Pendleton         
United States, Hawaii
University of Hawaii Cancer Center Active, not recruiting
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Site Public Contact    808-983-6090      
Principal Investigator: Wade T. Kyono         
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eugenia Chang         
United States, Illinois
Lurie Children's Hospital-Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Joanna L. Weinstein         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Site Public Contact    312-355-3046      
Principal Investigator: Mary L. Schmidt         
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Site Public Contact    773-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
Principal Investigator: Jennifer L. McNeer         
Advocate Children's Hospital-Oak Lawn Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Rebecca E. McFall         
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Site Public Contact    888-226-4343      
Principal Investigator: Pedro A. De Alarcon         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    217-545-7929      
Principal Investigator: Gregory P. Brandt         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    800-248-1199      
Principal Investigator: Kamnesh R. Pradhan         
Saint Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Site Public Contact    317-338-2194    research@stvincent.org   
Principal Investigator: Bassem I. Razzouk         
United States, Iowa
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Wendy L. Woods-Swafford         
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Site Public Contact    800-237-1225      
Principal Investigator: Mariko Sato         
United States, Kentucky
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Site Public Contact    859-257-3379      
Principal Investigator: Vlad C. Radulescu         
Norton Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Ashok B. Raj         
United States, Louisiana
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Site Public Contact    504-703-8712    Gregory.Johnstone@ochsner.org   
Principal Investigator: Craig Lotterman         
United States, Maine
Maine Children's Cancer Program Recruiting
Scarborough, Maine, United States, 04074
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Aaron R. Weiss         
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Site Public Contact    410-601-6120    pridgely@lifebridgehealth.org   
Principal Investigator: Jason M. Fixler         
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Site Public Contact    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Stacy L. Cooper         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Site Public Contact    877-726-5130      
Principal Investigator: Kimberly J. Davies         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Site Public Contact    877-442-3324      
Principal Investigator: Kimberly J. Davies         
United States, Michigan
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Meret Henry         
Ascension Saint John Hospital Recruiting
Detroit, Michigan, United States, 48236
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Adonis N. Lorenzana         
Michigan State University Clinical Center Recruiting
East Lansing, Michigan, United States, 48824-7016
Contact: Site Public Contact    517-975-9547      
Principal Investigator: Renuka Gera         
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: David S. Dickens         
Beaumont Children's Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Site Public Contact    248-551-0360      
Principal Investigator: Laura K. Gowans         
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Michael K. Richards         
University of Minnesota/Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Peter M. Gordon         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Site Public Contact    855-776-0015      
Principal Investigator: Carola A. Arndt         
United States, Mississippi
University of Mississippi Medical Center Suspended
Jackson, Mississippi, United States, 39216
United States, Missouri
Columbia Regional Recruiting
Columbia, Missouri, United States, 65201
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Barbara A. Gruner         
The Childrens Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jaszianne A. Tolbert         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Robert J. Hayashi         
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Site Public Contact    314-251-6770      
Principal Investigator: Bethany G. Sleckman         
United States, Nebraska
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Minnie Abromowitch         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Site Public Contact    402-559-6941    unmcrsa@unmc.edu   
Principal Investigator: Minnie Abromowitch         
United States, Nevada
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Sunrise Hospital and Medical Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Recruiting
Las Vegas, Nevada, United States, 89135
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Alan K. Ikeda         
Summerlin Hospital Medical Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Site Public Contact    800-639-6918    cancer.research.nurse@dartmouth.edu   
Principal Investigator: Sara Chaffee         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Site Public Contact    201-996-2879      
Principal Investigator: Burton E. Appel         
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Site Public Contact    973-971-5900      
Principal Investigator: Steven L. Halpern         
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Site Public Contact    732-235-8675      
Principal Investigator: Richard A. Drachtman         
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Site Public Contact    973-926-7230      
Principal Investigator: Teena Bhatla         
Saint Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Alissa Kahn         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Site Public Contact    505-925-0366    LByatt@nmcca.org   
Principal Investigator: John F. Kuttesch         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Site Public Contact    518-262-5513      
Principal Investigator: Kenneth G. Lucas         
Montefiore Medical Center - Moses Campus Recruiting
Bronx, New York, United States, 10467
Contact: Site Public Contact    718-379-6866    aaraiza@montefiore.org   
Principal Investigator: Lisa Gennarini         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Site Public Contact    800-767-9355    askroswell@roswellpark.org   
Principal Investigator: Matthew J. Barth         
NYU Winthrop Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Site Public Contact    516-663-3115      
Principal Investigator: Mark E. Weinblatt         
The Steven and Alexandra Cohen Children's Medical Center of New York Recruiting
New Hyde Park, New York, United States, 11040
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Arlene S. Redner         
Laura and Isaac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Site Public Contact    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Sharon L. Gardner         
Columbia University/Herbert Irving Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Site Public Contact    212-305-6361    nr2616@cumc.columbia.edu   
Principal Investigator: Alice Lee         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Site Public Contact    212-639-7592      
Principal Investigator: Neerav N. Shukla         
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
Contact: Site Public Contact    212-746-1848      
Principal Investigator: Lisa G. Roth         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Site Public Contact    585-275-5830      
Principal Investigator: Angela R. Girvin         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Site Public Contact    315-464-5476      
Principal Investigator: Philip M. Monteleone         
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Site Public Contact    914-594-3794      
Principal Investigator: Jessica C. Hochberg         
United States, North Carolina
Mission Hospital Inc-Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Site Public Contact    828-213-4150    leslie.verner@msj.org   
Principal Investigator: Douglas J. Scothorn         
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Site Public Contact    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Stuart H. Gold         
Carolinas Medical Center/Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Site Public Contact    704-355-2884      
Principal Investigator: Joel A. Kaplan         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Site Public Contact    888-275-3853      
Principal Investigator: Susan G. Kreissman         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Site Public Contact    336-713-6771      
Principal Investigator: Thomas B. Russell         
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Steven J. Kuerbitz         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Maureen M. O'Brien         
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Site Public Contact    216-844-5437      
Principal Investigator: John J. Letterio         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Aron Flagg         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mark A. Ranalli         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Ayman A. El-Sheikh         
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Site Public Contact    419-824-1842      
Principal Investigator: Jamie L. Dargart         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Oregon
Legacy Emanuel Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Janice F. Olson         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Site Public Contact    503-494-1080    trials@ohsu.edu   
Principal Investigator: Linda C. Stork         
United States, Pennsylvania
Lehigh Valley Hospital - Muhlenberg Active, not recruiting
Bethlehem, Pennsylvania, United States, 18017
Penn State Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Lisa M. McGregor         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Anne F. Reilly         
Saint Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Gregory E. Halligan         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jean M. Tersak         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Site Public Contact    401-444-1488      
Principal Investigator: Jennifer J. Greene Welch         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Site Public Contact    843-792-9321    hcc-clinical-trials@musc.edu   
Principal Investigator: Jacqueline M. Kraveka         
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Site Public Contact    803-434-3680      
Principal Investigator: Stuart L. Cramer         
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nichole L. Bryant         
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Site Public Contact    605-312-3320    OncologyClinicalTrialsSF@SanfordHealth.org   
Principal Investigator: Kayelyn J. Wagner         
United States, Tennessee
T C Thompson Children's Hospital Suspended
Chattanooga, Tennessee, United States, 37403
East Tennessee Childrens Hospital Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Site Public Contact    865-541-8266      
Principal Investigator: Ray C. Pais         
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Wayne L. Furman         
The Children's Hospital at TriStar Centennial Recruiting
Nashville, Tennessee, United States, 37203
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Haydar A. Frangoul         
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Site Public Contact    800-811-8480      
Principal Investigator: Debra L. Friedman         
United States, Texas
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Amy C. Fowler         
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nkechi I. Mba         
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Site Public Contact    972-566-5588      
Principal Investigator: Stanton C. Goldman         
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Site Public Contact    214-648-7097    canceranswerline@UTSouthwestern.edu   
Principal Investigator: Martha M. Pacheco         
El Paso Children's Hospital Recruiting
El Paso, Texas, United States, 79905
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Lisa L. Hartman         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Kenneth M. Heym         
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    713-798-1354    burton@bcm.edu   
Principal Investigator: Kala Y. Kamdar         
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Timothy C. Griffin         
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Vinod K. Gidvani-Diaz         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact    210-450-3800    phoresearchoffice@uthscsa.edu   
Principal Investigator: Anne-Marie R. Langevin         
Scott and White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Site Public Contact    254-724-5407      
Principal Investigator: Guy H. Grayson         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Phillip E. Barnette         
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Site Public Contact    703-208-6650    Stephanie.VanBebber@inova.org   
Principal Investigator: Marshall A. Schorin         
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eric J. Lowe         
Naval Medical Center - Portsmouth Active, not recruiting
Portsmouth, Virginia, United States, 23708-2197
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Site Public Contact       mwellons@vcu.edu   
Principal Investigator: Christina M. Wiedl         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Judy L. Felgenhauer         
Mary Bridge Children's Hospital and Health Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Robert G. Irwin         
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Site Public Contact    253-968-0129    mamcdci@amedd.army.mil   
Principal Investigator: Melissa A. Forouhar         
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Site Public Contact    800-622-8922      
Principal Investigator: Kenneth B. De Santes         
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Site Public Contact    414-955-4727    MACCCTO@mcw.edu   
Principal Investigator: Paul D. Harker-Murray         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Eric Lowe Children's Oncology Group

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01979536     History of Changes
Other Study ID Numbers: NCI-2013-02167
NCI-2013-02167 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
s14-01970
COG-ANHL12P1
ANHL12P1 ( Other Identifier: Childrens Oncology Group )
ANHL12P1 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Dexamethasone acetate
Dexamethasone
Liposomal doxorubicin
Etoposide phosphate
Isophosphamide mustard
Cyclophosphamide
Doxorubicin
Methotrexate
Etoposide
Cytarabine
Ifosfamide
Podophyllotoxin
BB 1101
Crizotinib
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents