Phase I Trial and Pharmacokinetic Study of Arsenic Trioxide in Pediatric Patients With Refractory Leukemia or Lymphoma
OBJECTIVES:
- Determine the toxic effects of arsenic trioxide in pediatric patients with refractory
leukemia or lymphoma.
- Determine the maximum tolerated dose of this drug in this patient population.
- Determine the plasma pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
disease (acute promyelocytic leukemia [APL] vs non-APL).
- Stratum I (APL patients): Patients receive standard-dose arsenic trioxide IV over 2
hours daily 5 days a week for 4 weeks. Treatment continues every 6 weeks for up to 3
courses in the absence of disease progression or unacceptable toxicity.
- Stratum II (Non-APL patients): Cohorts of 3-6 patients receive escalating doses of
arsenic trioxide (according to the stratum 1 schedule above) until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the
MTD is determined, additional patients are accrued to receive treatment with arsenic
trioxide at the recommended phase II dose.
Leukemia patients in both strata without progressive disease who have not achieved complete
remission after the first 20 doses may continue to receive arsenic trioxide for 2 additional
weeks.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for stratum I of this study
within 2-3 years. A total of 3-30 patients will be accrued for stratum II of this study
within 1-2 years.
Interventional
Primary Purpose: Treatment
Frank M. Balis, MD
Study Chair
National Cancer Institute (NCI)
United States: Federal Government
CDR0000067717
NCT00020111
March 2000
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
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 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
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 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
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 of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Floating Hospital for Children | Boston, Massachusetts 02111 |
Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
Texas Children's Cancer Center | Houston, Texas 77030-2399 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
St. Louis Children's Hospital | Saint Louis, Missouri 63110 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland, Ohio 44106 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Lucile Packard Children's Hospital at Stanford University Medical Center | Palo Alto, California 95798 |
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus | Atlanta, Georgia 30342 |
Riley Children Cancer Center at Riley Hospital for Children | Indianapolis, Indiana 46202-5225 |
Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Vanderbilt Children's Hospital | Nashville, Tennessee 37232-6310 |
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390-9063 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
MD Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
County of Los Angeles Harbor-UCLA Medical Center | Torrance, California 90509 |