Spots Global Cancer Trial Database for Lorvotuzumab Mertansine in Treating Younger Patients With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor, or Synovial Sarcoma
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Trial Identification
Brief Title: Lorvotuzumab Mertansine in Treating Younger Patients With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor, or Synovial Sarcoma
Official Title: A Phase 2 Study of IMGN901 (Lorvotuzumab Mertansine; NSC#: 783609) in Children With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor (MPNST) and Synovial Sarcoma
Study ID: NCT02452554
Study Description
Brief Summary: This phase II trial studies how well lorvotuzumab mertansine works in treating younger patients with Wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary blastoma, malignant peripheral nerve sheath tumor (MPNST), or synovial sarcoma that has returned or that does not respond to treatment. Antibody-drug conjugates, such as lorvotuzumab mertansine, are created by attaching an antibody (protein used by the body?s immune system to fight foreign or diseased cells) to an anti-cancer drug. The antibody is used to recognize tumor cells so the anti-cancer drug can kill them.
Detailed Description: PRIMARY OBJECTIVES: I. To assess the efficacy of IMGN901 (lorvotuzumab mertansine) in Wilms tumor, rhabdomyosarcoma, neuroblastoma and other cluster of differentiation (CD)56-expressing tumors such as pleuropulmonary blastoma, malignant peripheral nerve sheath tumor (MPNST) and synovial sarcoma. II. To determine the tolerability of the adult recommended phase 2 dose (RP2D) of IMGN901 administered as an intravenous infusion, administered on days 1 and 8 of a 21-day cycle, to children with refractory Wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary blastoma, MPNST, or synovial sarcoma. III. To define and describe the toxicities of IMGN901 administered on this schedule. EXPLORATORY OBJECTIVES: I. To correlate tumor response with tumor CD56+ expression. II. To characterize the pharmacokinetics of IMGN901 in children with refractory cancer, including an assessment of impact on circulating CD56+ peripheral blood cells. OUTLINE: Patients receive lorvotuzumab mertansine intravenously (IV) over 1-1.5 hours on days 1 and 8. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.
Keywords
Eligibility
Minimum Age: 12 Months
Eligible Ages: CHILD, 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
Loma Linda University Medical Center, Loma Linda, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Children's Hospital and Research Center at Oakland, Oakland, California, United States
Children's Hospital of Orange County, Orange, 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
Yale University, New Haven, Connecticut, United States
Alfred I duPont Hospital for Children, Wilmington, Delaware, 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
Nicklaus Children's Hospital, Miami, Florida, United States
AdventHealth Orlando, Orlando, Florida, United States
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Saint Luke's Mountain States Tumor Institute, Boise, Idaho, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, 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
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
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Ascension Saint John Hospital, Detroit, Michigan, United States
Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, 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
Mayo Clinic, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Mount Sinai Hospital, New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Rainbow Babies and Childrens Hospital, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Prisma Health Richland Hospital, Columbia, South Carolina, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas, Austin, 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
Primary Children's Hospital, Salt Lake City, Utah, United States
University of Vermont and State Agricultural College, Burlington, Vermont, 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
West Virginia University Healthcare, Morgantown, West Virginia, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: James I Geller
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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