A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

February 16, 2021

Primary Completion Date

December 30, 2026

Study Completion Date

December 30, 2026

Conditions
Recurrent Low Grade AstrocytomaRecurrent WHO Grade 2 GliomaRefractory Low Grade AstrocytomaRefractory Low Grade GliomaRefractory WHO Grade 1 Glioma
Interventions
PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Selumetinib Sulfate

Given PO

DRUG

Vinblastine Sulfate

Given IV

Trial Locations (101)

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10595

New York Medical College, Valhalla

11040

The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park

12208

Albany Medical Center, Albany

13210

State University of New York Upstate Medical University, Syracuse

14263

Roswell Park Cancer Institute, Buffalo

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

19134

Saint Christopher's Hospital for Children, Philadelphia

19803

Alfred I duPont Hospital for Children, Wilmington

20010

Children's National Medical Center, Washington D.C.

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

23298

VCU Massey Comprehensive Cancer Center, Richmond

23507

Children's Hospital of The King's Daughters, Norfolk

26506

West Virginia University Healthcare, Morgantown

27157

Wake Forest University Health Sciences, Winston-Salem

27710

Duke University Medical Center, Durham

27834

East Carolina University, Greenville

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

29203

Prisma Health Richland Hospital, Columbia

29605

BI-LO Charities Children's Cancer Center, Greenville

30329

Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta

32207

Nemours Children's Clinic-Jacksonville, Jacksonville

32610

University of Florida Health Science Center - Gainesville, Gainesville

32806

Arnold Palmer Hospital for Children, Orlando

32827

Nemours Children's Hospital, Orlando

33021

Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood

33607

Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa

33701

Johns Hopkins All Children's Hospital, St. Petersburg

33908

Golisano Children's Hospital of Southwest Florida, Fort Myers

35233

Children's Hospital of Alabama, Birmingham

37232

Vanderbilt University/Ingram Cancer Center, Nashville

37916

East Tennessee Childrens Hospital, Knoxville

39216

University of Mississippi Medical Center, Jackson

40202

Norton Children's Hospital, Louisville

43205

Nationwide Children's Hospital, Columbus

44308

Children's Hospital Medical Center of Akron, Akron

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

45404

Dayton Children's Hospital, Dayton

46202

Riley Hospital for Children, Indianapolis

46260

Ascension Saint Vincent Indianapolis Hospital, Indianapolis

48073

Corewell Health Children's, Royal Oak

48109

C S Mott Children's Hospital, Ann Arbor

48201

Children's Hospital of Michigan, Detroit

49503

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53226

Children's Hospital of Wisconsin, Milwaukee

53792

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

55404

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis

55455

University of Minnesota/Masonic Cancer Center, Minneapolis

55905

Mayo Clinic in Rochester, Rochester

58122

Sanford Broadway Medical Center, Fargo

60611

Lurie Children's Hospital-Chicago, Chicago

60612

University of Illinois, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

63104

Cardinal Glennon Children's Medical Center, St Louis

63110

Washington University School of Medicine, St Louis

64108

Children's Mercy Hospitals and Clinics, Kansas City

68114

Children's Hospital and Medical Center of Omaha, Omaha

68198

University of Nebraska Medical Center, Omaha

70118

Children's Hospital New Orleans, New Orleans

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

76104

Cook Children's Medical Center, Fort Worth

77030

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston

M D Anderson Cancer Center, Houston

78207

Children's Hospital of San Antonio, San Antonio

78229

University of Texas Health Science Center at San Antonio, San Antonio

78723

Dell Children's Medical Center of Central Texas, Austin

80045

Children's Hospital Colorado, Aurora

83712

Saint Luke's Cancer Institute - Boise, Boise

84113

Primary Children's Hospital, Salt Lake City

87106

University of New Mexico Cancer Center, Albuquerque

90027

Children's Hospital Los Angeles, Los Angeles

92354

Loma Linda University Medical Center, Loma Linda

92868

Children's Hospital of Orange County, Orange

94304

Lucile Packard Children's Hospital Stanford University, Palo Alto

94611

Kaiser Permanente-Oakland, Oakland

97239

Oregon Health and Science University, Portland

98105

Seattle Children's Hospital, Seattle

98431

Madigan Army Medical Center, Tacoma

99204

Providence Sacred Heart Medical Center and Children's Hospital, Spokane

72202-3591

Arkansas Children's Hospital, Little Rock

06106

Connecticut Children's Medical Center, Hartford

06520

Yale University, New Haven

04074

Maine Children's Cancer Program, Scarborough

20889-5600

Walter Reed National Military Medical Center, Bethesda

02215

Dana-Farber Cancer Institute, Boston

07960

Morristown Medical Center, Morristown

08903

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick

T6G 2B7

University of Alberta Hospital, Edmonton

V6H 3V4

British Columbia Children's Hospital, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

B3K 6R8

IWK Health Centre, Halifax

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

Hospital for Sick Children, Toronto

H3H 1P3

The Montreal Children's Hospital of the MUHC, Montreal

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke

G1V 4G2

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL), Québec

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT04576117 - A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma | Biotech Hunter | Biotech Hunter