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Spots Global Cancer Trial Database for Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma

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Trial Identification

Brief Title: Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma

Official Title: A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab With or Without Eflornithine (DFMO) in Children With Relapsed, Refractory or Progressive Neuroblastoma

Study ID: NCT03794349

Study Description

Brief Summary: This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back (relapsed) or that isn't responding to treatment (refractory). Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, 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. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.

Detailed Description: PRIMARY OBJECTIVE: I. To determine whether administration of eflornithine hydrochloride (eflornithine \[DFMO\]) in combination with dinutuximab, irinotecan hydrochloride (irinotecan) and temozolomide results in an improved response rate compared to dinutuximab, irinotecan and temozolomide in patients with relapsed or refractory neuroblastoma and therefore is a therapeutic regimen worthy of further testing in patients with newly-diagnosed high-risk neuroblastoma. SECONDARY OBJECTIVES: I. To compare progression-free survival and overall survival between patients receiving dinutuximab, irinotecan and temozolomide with and without the addition of DFMO. II. To define the toxicity profile of DFMO administered with dinutuximab, irinotecan and temozolomide. EXPLORATORY OBJECTIVES: I. To characterize the immune and cytokine profiles of patients treated with DFMO/chemotherapy/dinutuximab combination and correlate with response to therapy. II. To evaluate GD2 levels in tumor cells from patient bone marrow samples and correlate with response to therapy. III. To explore whether the addition of DFMO to the dinutuximab and chemotherapy backbone affects pain as determined by patient report and opiate usage. OUTLINE: Patients are randomized to 1 of 2 regimens. REGIMEN A: Patients receive temozolomide orally (PO), via nasogastric (NG), or gastric (G) tube on days 1-5, irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim subcutaneously (SC) or IV over 2 hours on days 6-12 of a 21-day cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. REGIMEN B: Patients receive eflornithine PO, via NG, or G tube on days -6 to 7 and days 15-21 of cycle 1 and days 1-7 and 15-21 of subsequent cycles, temozolomide PO, via NG, or G tube on days 1-5, irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Treatment lasts 28 days for cycle 1 and then every 21 days for subsequent cycles up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and periodically for 5 years.

Keywords

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Children's Hospital of Alabama, Birmingham, Alabama, United States

Arkansas Children's Hospital, Little Rock, Arkansas, United States

Kaiser Permanente Downey Medical Center, Downey, California, United States

Miller Children's and Women's Hospital Long Beach, Long Beach, California, United States

Children's Hospital Los Angeles, Los Angeles, California, United States

Cedars Sinai Medical Center, Los Angeles, California, United States

Valley Children's Hospital, Madera, California, United States

Kaiser Permanente-Oakland, Oakland, California, United States

Children's Hospital of Orange County, Orange, California, United States

Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Rady Children's Hospital - San Diego, San Diego, California, United States

UCSF Medical Center-Mission Bay, San Francisco, California, United States

Children's Hospital Colorado, Aurora, Colorado, United States

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver, Colorado, United States

Connecticut Children's Medical Center, Hartford, Connecticut, United States

Yale University, New Haven, Connecticut, United States

Alfred I duPont Hospital for Children, Wilmington, Delaware, United States

MedStar Georgetown University Hospital, Washington, District of Columbia, United States

Children's National Medical Center, Washington, District of Columbia, United States

Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States

University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood, Florida, United States

Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States

Nicklaus Children's Hospital, Miami, Florida, United States

Arnold Palmer Hospital for Children, Orlando, Florida, United States

Nemours Children's Hospital, Orlando, Florida, United States

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States

Saint Mary's Hospital, West Palm Beach, Florida, United States

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States

Memorial Health University Medical Center, Savannah, Georgia, United States

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States

Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States

Lurie Children's Hospital-Chicago, Chicago, Illinois, United States

University of Illinois, Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Loyola University Medical Center, Maywood, Illinois, United States

Saint Jude Midwest Affiliate, Peoria, Illinois, United States

Riley Hospital for Children, Indianapolis, Indiana, United States

Ascension Saint Vincent Indianapolis Hospital, Indianapolis, Indiana, United States

Blank Children's Hospital, Des Moines, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States

Norton Children's Hospital, Louisville, Kentucky, United States

Children's Hospital New Orleans, New Orleans, Louisiana, United States

Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States

Eastern Maine Medical Center, Bangor, Maine, United States

Maine Children's Cancer Program, Scarborough, Maine, United States

University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States

Sinai Hospital of Baltimore, Baltimore, Maryland, United States

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

C S Mott Children's Hospital, Ann Arbor, Michigan, United States

Children's Hospital of Michigan, Detroit, Michigan, United States

Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

Michigan State University Clinical Center, East Lansing, Michigan, United States

Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

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

University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Mercy Hospital Saint Louis, Saint Louis, Missouri, United States

Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

University Medical Center of Southern Nevada, Las Vegas, Nevada, United States

Sunrise Hospital and Medical Center, Las Vegas, Nevada, United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas, Nevada, United States

Summerlin Hospital Medical Center, Las Vegas, Nevada, United States

Renown Regional Medical Center, Reno, Nevada, United States

Hackensack University Medical Center, Hackensack, New Jersey, United States

Morristown Medical Center, Morristown, New Jersey, United States

Albany Medical Center, Albany, New York, United States

Montefiore Medical Center - Moses Campus, Bronx, New York, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

NYU Winthrop Hospital, Mineola, New York, United States

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

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States

University of Rochester, Rochester, New York, United States

State University of New York Upstate Medical University, Syracuse, New York, United States

Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States

Duke University Medical Center, Durham, North Carolina, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Children's Hospital Medical Center of Akron, Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Rainbow Babies and Childrens Hospital, Cleveland, Ohio, United States

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Nationwide Children's Hospital, Columbus, Ohio, United States

Dayton Children's Hospital, Dayton, Ohio, United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Oregon Health and Science University, Portland, Oregon, United States

Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States

Penn State Children's Hospital, Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

Rhode Island Hospital, Providence, Rhode Island, United States

Prisma Health Richland Hospital, Columbia, South Carolina, United States

BI-LO Charities Children's Cancer Center, Greenville, South Carolina, United States

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States

East Tennessee Childrens Hospital, Knoxville, Tennessee, United States

Saint Jude Children's Research Hospital, Memphis, Tennessee, United States

The Children's Hospital at TriStar Centennial, Nashville, Tennessee, United States

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

Dell Children's Medical Center of Central Texas, Austin, Texas, United States

Driscoll Children's Hospital, Corpus Christi, Texas, United States

Medical City Dallas Hospital, Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

Cook Children's Medical Center, Fort Worth, Texas, United States

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

Children's Hospital of San Antonio, San Antonio, Texas, United States

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

Primary Children's Hospital, Salt Lake City, Utah, United States

University of Vermont and State Agricultural College, Burlington, Vermont, United States

University of Virginia Cancer Center, Charlottesville, Virginia, United States

Children's Hospital of The King's Daughters, Norfolk, Virginia, United States

Seattle Children's Hospital, Seattle, Washington, United States

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

Mary Bridge Children's Hospital and Health Center, Tacoma, Washington, United States

Madigan Army Medical Center, Tacoma, Washington, United States

West Virginia University Healthcare, Morgantown, West Virginia, United States

University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States

John Hunter Children's Hospital, Hunter Regional Mail Centre, New South Wales, Australia

Sydney Children's Hospital, Randwick, New South Wales, Australia

The Children's Hospital at Westmead, Westmead, New South Wales, Australia

Queensland Children's Hospital, South Brisbane, Queensland, Australia

Women's and Children's Hospital-Adelaide, North Adelaide, South Australia, Australia

Royal Children's Hospital, Parkville, Victoria, Australia

Perth Children's Hospital, Perth, Western Australia, Australia

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Janeway Child Health Centre, Saint John's, Newfoundland and Labrador, Canada

IWK Health Centre, Halifax, Nova Scotia, Canada

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada

Kingston Health Sciences Centre, Kingston, Ontario, Canada

Children's Hospital, London, Ontario, Canada

Hospital for Sick Children, Toronto, Ontario, Canada

The Montreal Children's Hospital of the MUHC, Montreal, Quebec, Canada

Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke, Quebec, Canada

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

Starship Children's Hospital, Grafton, Auckland, New Zealand

Christchurch Hospital, Christchurch, , New Zealand

HIMA San Pablo Oncologic Hospital, Caguas, , Puerto Rico

Contact Details

Name: Margaret E Macy

Affiliation: Children's Oncology Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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