A Trial of MGI 114 in Children With Solid Tumors: A Pediatric Oncology Group Phase I Cooperative Agreement Study
OBJECTIVES:
I. Determine the maximum tolerated dose and dose limiting toxicity of
6-hydroxymethylacylfulvene (MGI-114) in pediatric patients with recurrent or refractory
solid tumors.
II. Determine the incidence and severity of other toxic effects of MGI-114. III. Determine a
safe and tolerable dose of MGI-114 to be used in phase II studies.
IV. Determine the pharmacokinetics of MGI-114 in these patients. V. Determine preliminary
evidence of antitumor activity of MGI-114 against recurrent or refractory pediatric solid
tumors.
OUTLINE: This is a dose escalation study. If the dose limiting toxicity is myelosuppression
in stratum 1, then stratum 1 is closed and stratum 2 opens.
Stratum 2 consists of the following: patients receiving no more than 2 prior chemotherapy
regimens; patients who have not received prior central axis radiation or bone marrow
transplantation; and patients with no known bone marrow involvement. Patients receive
intravenous 6-hydroxymethylacylfulvene over 10 minutes daily for 5 days. The course is
repeated every 28 days unless disease progression or unacceptable toxic effects are
observed. Patients with stable or responding disease may receive up to 1 year of therapy. If
dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then dose escalation
ceases and the next lower dose is declared the maximum tolerated dose. Dose escalation will
not occur until all patients within a cohort have been observed for 28 days from day 1 of
therapy. Patients are followed until death.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Gail C. Megason, MD
Study Chair
University of Mississippi Cancer Clinic
United States: Food and Drug Administration
NCI-2012-01838
NCT00003370
August 1998
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Children's Hospital of Michigan | Detroit, Michigan 48201 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Boston Floating Hospital Infants and Children | Boston, Massachusetts 02111 |
University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
Children's Hospital of Orange County | Orange, California 92668 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Children's Mercy Hospital | Kansas City, Missouri 64108 |
Children's Hospital Medical Center - Cincinnati | Cincinnati, Ohio 45229-3039 |
Children's Hospital of Columbus | Columbus, Ohio 43205-2696 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
Texas Children's Cancer Center | Houston, Texas 77030-2399 |
Columbia Presbyterian Hospital | New York, New York 10032 |
Children's Memorial Hospital, Chicago | Chicago, Illinois 60614 |
Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Veterans Affairs Medical Center - Huntington | Huntington, West Virginia 25704 |