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Dinutuximab in Combination with Sargramostim in Treating Patients with Recurrent Osteosarcoma

Trial Status: Closed to Accrual and Intervention

This phase II trial studies how well dinutuximab works when given with sargramostim in treating patients with osteosarcoma that has come back after treatment (recurrent). Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them. Sargramostim may help the body increase the amount of white blood cells it produces, which help the body fight off infections. Giving dinutuximab with sargramostim may work better and kill more cancer cells.

Inclusion Criteria

  • Patients must have histologic diagnosis of osteosarcoma at original diagnosis
  • Patients must have had at least one episode of disease recurrence in the lungs without limitation on number of episodes of recurrence as long as they meet the following criteria: * Surgical resection of all possible sites of suspected pulmonary metastases in order to achieve a complete remission within 4 weeks prior to study enrollment** * Pathologic confirmation of metastases from at least one of the resected sites ** For patients with bilateral pulmonary metastases, resection must be performed from both lungs and the study enrollment must be within 4 weeks from date of the last lung surgery * Note: If surgery related changes such as atelectasis are seen on the post-operative computed tomography (CT) scan, patients will remain eligible to enroll as long as the operating surgeon believes that all sites of metastases were resected; patients with positive microscopic margins will be eligible to enroll
  • Patient must have adequate tumor specimen available for submission
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study * Myelosuppressive anti-cancer therapy: must not have been received within 2 weeks of study entry (4 weeks if prior nitrosourea) * Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent * Radiation therapy (RT): >= 2 weeks for local palliative radiation therapy (RT) (small port); >= 6 weeks must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation * Surgery: >= 2 weeks from last major surgery, including pulmonary metastasectomy, with the exclusion of a central line placement and core needle or small open biopsies
  • Patient must not have received pegfilgrastim within 14 days of enrollment
  • Patient must not have received filgrastim (G-CSF, Neupogen) within 7 days of enrollment
  • Patient must not have received immune suppressants: corticosteroids (for other than allergic reactions and anaphylaxis), cyclosporine or tacrolimus within 7 days of enrollment * Note: the use of topical and/or inhalational steroids is allowed
  • Total absolute phagocyte count (APC = [%neutrophils + %monocytes) x white blood cells [WBC]) is at least 1000/uL
  • Platelet count >= 50,000/uL
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or
  • A serum creatinine based on age/gender as follows: * 1 month to < 6 months: 0.4 (male) 0.4 (female) * 6 months to < 1 year: 0.5 (male), 0.5 (female) * 1 to < 2 years: 0.6 (male), 0.6 (female) * 2 to < 6 years: 0.8 (male), 0.8 (female) * 6 to < 10 years: 1 (male), 1 (female) * 10 to < 13 years: 1.2 (male), 1.2 (female) * 13 to < 16 years: 1.5 (male), 1.4 (female) * >= 16 years: 1.7 (male), 1.4 (female)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L (for the purpose of this study, the ULN for SGPT is 45 U/L)
  • Serum albumin >= 2 g/dL
  • Baseline electrocardiogram (EKG) shows normal corrected QT interval (QTc) interval of =< 470 milliseconds (ms)
  • Shortening fraction of >= 27% by echocardiogram, or
  • Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
  • No evidence of dyspnea at rest, no history of exercise intolerance, and a pulse oximetry > 94%
  • Patient has no known history of seizure disorder
  • Central nervous system (CNS) toxicity including peripheral neuropathy =< grade 2

Exclusion Criteria

  • Patients with distant bone metastases at original diagnosis or relapse (patients with only skip lesions will be eligible)
  • Patients with concurrent local and pulmonary recurrence at the time of enrollment; note: patients who had local recurrence previously that has been treated and now present with an isolated pulmonary recurrence and meet the surgical resection criteria stated above will be eligible
  • Patients with primary refractory disease with progression of the primary tumor on initial therapy
  • Patients with CNS disease or other sites of extra-pulmonary metastases at the time of most recent episode of disease recurrence preceding enrollment
  • Patients with a prior hypersensitivity reaction to sargramostim
  • Patients who have received prior anti-GD2 therapy, including chimeric antigen receptor (CAR) T cells directed against GD2 antigen
  • Female patients who are pregnant are ineligible
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
  • Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation; patients should maintain adequate contraception for a minimum of 2 months after the last dose of ch14.18 (dinutuximab)

Alabama

Birmingham
Children's Hospital of Alabama
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Arizona

Phoenix
Phoenix Childrens Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 602-546-0920

Arkansas

Little Rock
Arkansas Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

California

Downey
Kaiser Permanente Downey Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 626-564-3455
Loma Linda
Loma Linda University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 909-558-3375
Los Angeles
Children's Hospital Los Angeles
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Madera
Valley Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Oakland
Children's Hospital and Research Center at Oakland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Kaiser Permanente-Oakland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
Children's Hospital of Orange County
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Sacramento
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 916-734-3089
San Francisco
UCSF Medical Center-Mission Bay
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-827-3222

Colorado

Aurora
Children's Hospital Colorado
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Connecticut

Hartford
Connecticut Children's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
New Haven
Yale University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-651-6884

District of Columbia

Washington
Children's National Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Florida

Gainesville
University of Florida Health Science Center - Gainesville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Miami
Nicklaus Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Orlando
Arnold Palmer Hospital for Children
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 321-843-2584
Nemours Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Pensacola
Nemours Children's Clinic - Pensacola
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
West Palm Beach
Saint Mary's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Savannah
Memorial Health University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 912-350-7887

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-983-6090

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-8222
University of Illinois
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-355-3046
Peoria
Saint Jude Midwest Affiliate
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-226-4343
Springfield
Southern Illinois University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-545-7929

Indiana

Indianapolis
Riley Hospital for Children
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-248-1199
Saint Vincent Hospital and Health Care Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 317-338-2194

Iowa

Des Moines
Blank Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-257-3379
Louisville
Norton Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 504-703-8712

Maine

Bangor
Eastern Maine Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 207-973-4274

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 410-955-8804
Sinai Hospital of Baltimore
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 410-601-6120

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-442-3324
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-726-5130

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Detroit
Ascension Saint John Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Kalamazoo
Bronson Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Royal Oak
Beaumont Children's Hospital-Royal Oak
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-0360

Minnesota

Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
University of Minnesota / Masonic Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Kansas City
Children's Mercy Hospitals and Clinics
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Saint Louis
Cardinal Glennon Children's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Mercy Hospital Saint Louis
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-251-6770
Washington University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606

Nebraska

Omaha
Children's Hospital and Medical Center of Omaha
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
University of Nebraska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 402-559-6941

Nevada

Las Vegas
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Summerlin Hospital Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-639-6918

New Jersey

Hackensack
Hackensack University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 201-996-2879

New York

Albany
Albany Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 518-262-5513
Bronx
Montefiore Medical Center - Moses Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-379-6866
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-263-4434
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-305-6361
Rochester
University of Rochester
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 585-275-5830
Syracuse
State University of New York Upstate Medical University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 315-464-5476
Valhalla
New York Medical College
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 914-594-3794

North Carolina

Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 704-355-2884
Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-275-3853

North Dakota

Fargo
Sanford Broadway Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-437-4010

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Cleveland
Rainbow Babies and Childrens Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 216-844-5437
Columbus
Nationwide Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Dayton
Dayton Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Toledo
ProMedica Toledo Hospital / Russell J Ebeid Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Portland
Oregon Health and Science University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-494-1080

Pennsylvania

Philadelphia
Children's Hospital of Philadelphia
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Puerto Rico

San Juan
University Pediatric Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 787-474-0333

South Carolina

Greenville
BI-LO Charities Children's Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-312-3320

Tennessee

Memphis
Saint Jude Children's Research Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Nashville
The Children's Hospital at TriStar Centennial
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Corpus Christi
Driscoll Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Dallas
Medical City Dallas Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 214-648-7097
Fort Worth
Cook Children's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 713-798-1354
Lubbock
Covenant Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
San Antonio
Children's Hospital of San Antonio
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
University of Texas Health Science Center at San Antonio
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 210-450-3800

Utah

Salt Lake City
Primary Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Vermont

Burlington
University of Vermont and State Agricultural College
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 802-656-8990

Virginia

Norfolk
Children's Hospital of The King's Daughters
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Washington

Seattle
Seattle Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Tacoma
Madigan Army Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-968-0129

West Virginia

Morgantown
West Virginia University Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 304-293-7374

Wisconsin

Milwaukee
Children's Hospital of Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-955-4727

Alberta

Calgary
Alberta Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Manitoba

Winnipeg
CancerCare Manitoba
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 866-561-1026

Nova Scotia

Halifax
IWK Health Centre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 902-470-6767

Ontario

London
Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Toronto
Hospital for Sick Children
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 416-813-7654ext2027

Quebec

Montreal
Centre Hospitalier Universitaire Sainte-Justine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 514-345-4931
The Montreal Children's Hospital of the MUHC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Quebec
Centre Hospitalier Universitaire de Quebec
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Australia

Clayton
Monash Medical Center-Clayton Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: (03) 9928 8111
Hunter Regional Mail Centre
John Hunter Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
North Adelaide
Women's and Children's Hospital-Adelaide
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Parkville
Royal Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Perth
Princess Margaret Hospital for Children
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: (08) 9340 8222
Randwick
Sydney Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
South Brisbane
Queensland Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Westmead
The Children's Hospital at Westmead
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

New Zealand

Christchurch
Christchurch Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 03 364 0640
Grafton
Starship Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

PRIMARY OBJECTIVES:

I. To determine the disease control rate in patients with completely resected recurrent osteosarcoma treated with ch14.18 (dinutuximab) in combination with sargramostim (granulocyte-macrophage colony-stimulating factor [GM-CSF]) as compared to historical Children's Oncology Group (COG) experience.

SECONDARY OBJECTIVES:

I. To characterize the pharmacokinetics of ch14.18 (dinutuximab) in patients with recurrent osteosarcoma.

II. To determine the occurrence of unacceptable toxicity (UT) in patients with recurrent osteosarcoma treated with ch14.18 (dinutuximab) in combination with sargramostim.

III. To assess the relationship between probability of disease control and tumor ganglioside GD2 (GD2) expression.

TERTIARY OBJECTIVES:

I. To assess the relationship between probability of disease control and tumor GD2 expression.

II. To assess KIR and Fcgamma receptor (FcgammaR) genotypes, NKp30 isoforms and its circulating ligand, B7-H6, and their relationships to the probability of disease control.

III. To attempt banking of tumor samples for future research studies from patients enrolled on study who undergo biopsy or resection of suspected metastatic disease recurrence while on protocol therapy or during the evaluation period.

IV. To determine a descriptive profile of human anti-chimeric antibody (HACA) during immunotherapy.

V. To bank serial plasma samples for future studies of circulating tumor deoxyribonucleic acid (ctDNA) detection as a marker of disease progression and response.

OUTLINE:

Patients receive sargramostim subcutaneously (SC) once daily (QD) on days 1-14 and dinutuximab intravenously (IV) over 10 hours on days 4-7 (dinutuximab infusion may be extended up to a total of 20 hours per day for anticipated toxicities). Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 8 and 12 months.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Children's Oncology Group

Principal Investigator
Pooja Hingorani

  • Primary ID AOST1421
  • Secondary IDs NCI-2015-01001, s16-00451
  • Clinicaltrials.gov ID NCT02484443