Spots Global Cancer Trial Database for Phase I Study of GNKG168 in Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia
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Trial Identification
Brief Title: Phase I Study of GNKG168 in Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia
Official Title: A Phase I Study of GNKG168 in Pediatric Patients With Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia (IND#113600)
Study ID: NCT01743807
Interventions
Study Description
Brief Summary: This is a phase I trial of an investigational drug called GNKG168 in patients with relapsed and refractory acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) who are in morphologic remission but are positive for Minimum Residual Disease (MRD). GNKG168 is a Toll-like receptor (TLR) agonist. TLR agonists are a novel approach to stimulate an effective anti-tumor immune response as they are able to stimulate both innate and adaptive immune responses. There will be two strata i.e patients who have received hematopoietic stem cell transplant (HSCT) and patients who have never undergone HSCT. GNKG168 will be administered as a 60 min iv infusion. One 14-day cycle consists of 5-day treatment followed by 9 day-rest. Patients will receive 2 cycles before evaluation. The primary objective is to determine the maximum tolerated dose of GNKG168 in relapsed ALL and AML patients.
Detailed Description:
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Phoenix Children's Hospital, Phoenix, Arizona, United States
Miller Children's Hospital, Long Beach, California, United States
Childrens Hospital Los Angeles, Los Angeles, California, United States
Oakland Children's Hospital, Oakland, California, United States
Stanford University Medical Center, Palo Alto, California, United States
UCSF School of Medicine, San Francisco, California, United States
The Children's Hospital, University of Colorado, Aurora, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
University of Miami Cancer Center, Miami, Florida, United States
Children's Healthcare of Atlanta, Emory University, Atlanta, Georgia, United States
Children's Memorial, Chicago, Illinois, United States
Johns Hopkins University, Baltimore, Maryland, United States
Dana Farber, Boston, Massachusetts, United States
C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States
Childrens Hospital & Clinics of Minnesota, Minneapolis, Minnesota, United States
University of Minnesota Children's Hospital, Minneapolis, Minnesota, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
New York University Medical Center, New York, New York, United States
Children's Hospital New York-Presbyterian, New York, New York, United States
Memorial Sloan Kettering, New York, New York, United States
Levine Children's Hospital at Carolinas Medical Center, Charlotte, North Carolina, United States
Nationwide Childrens Hospital, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
St. Jude, Memphis, Tennessee, United States
Vanderbilt Children's Hospital, Nashville, Tennessee, United States
University of Texas at Southwestern, Dallas, Texas, United States
Cook Children's Medical Center, Forth Worth, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
Contact Details
Name: Nobuko Hijiya, MD
Affiliation: Ann and Robert H. Lurie Children's Hospital of Chicago
Role: STUDY_CHAIR
Name: Kirk Schultz, MD
Affiliation: British Columbia Children's Hospital
Role: STUDY_CHAIR
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