Arsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma
NCT ID: NCT00020111
Last Updated: 2015-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
2000-03-31
Brief Summary
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PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide in treating young patients with leukemia or lymphoma.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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arsenic trioxide
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed leukemia or lymphoma refractory to standard curative treatment regimens
* Measurable or evaluable disease
* No meningeal leukemia or lymphoma
* No HIV-related lymphoma
* No lymphoproliferative diseases
PATIENT CHARACTERISTICS:
Age:
* 2 to 21
* Acute promyelocytic leukemia (APL) patients (stratum I) must be age 2 to 12
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin normal
* SGPT less than 2 times upper limit of normal
* No significant hepatic dysfunction that would preclude study therapy
Renal:
* Creatinine normal (age adjusted) OR
* Creatinine clearance at least 60 mL/min
* Potassium, magnesium, and calcium at least lower limit of normal (oral or IV supplementation allowed)
* No significant renal dysfunction that would preclude study therapy
Cardiovascular:
* Rate corrected QTc interval no greater than 0.48 on EKG
* No significant cardiac dysfunction that would preclude study therapy
* No cardiac disease, including dysrhythmias
Pulmonary:
* No significant pulmonary dysfunction that would preclude study therapy
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No persistent grade 3 or greater sensory or motor neuropathy
* No prior grand mal seizures (grade 3 or greater) within the past 2 years other than febrile seizures (except for patients with APL at discretion of investigator)
* No clinically significant unrelated systemic illness that would preclude study therapy (e.g., serious infection)
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 1 week since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], and epoetin alfa)
* No concurrent immunotherapy
Chemotherapy:
* No prior arsenic trioxide
* At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered
* No concurrent intrathecal chemotherapy except for acute promyelocytic leukemia (APL) patients experiencing progressive meningeal leukemia and demonstrating benefit from arsenic trioxide for systemic disease
* No other concurrent anticancer chemotherapy
Endocrine therapy:
* No concurrent steroids (except corticosteroids for retinoic acid syndrome)
Radiotherapy:
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* At least 6 months since prior anticonvulsants
* At least 1 week since prior retinoid therapy
* No concurrent retinoids
* No other concurrent investigational agents
2 Years
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Principal Investigators
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Frank M. Balis, MD
Role: STUDY_CHAIR
National Cancer Institute (NCI)
Locations
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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
County of Los Angeles Harbor-UCLA Medical Center
Torrance, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
Atlanta, Georgia, United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States
Riley Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
Floating Hospital for Children
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
Texas Children's Cancer Center
Houston, Texas, United States
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Royal Children's Hospital
Parkville, Victoria, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Countries
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References
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Fox E, Razzouk BI, Widemann BC, Xiao S, O'Brien M, Goodspeed W, Reaman GH, Blaney SM, Murgo AJ, Balis FM, Adamson PC. Phase 1 trial and pharmacokinetic study of arsenic trioxide in children and adolescents with refractory or relapsed acute leukemia, including acute promyelocytic leukemia or lymphoma. Blood. 2008 Jan 15;111(2):566-73. doi: 10.1182/blood-2007-08-107839. Epub 2007 Oct 24.
Fox E, Adamson PC, Murgo A, et al.: Phase 1 trial and pharmacokinetic study of arsenic trioxide in children with refractory leukemia. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1582, 2002.
Other Identifiers
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NCI-00-C-0070J
Identifier Type: -
Identifier Source: secondary_id
NCI-T99-0080
Identifier Type: -
Identifier Source: secondary_id
CDR0000067717
Identifier Type: -
Identifier Source: org_study_id
NCT00004548
Identifier Type: -
Identifier Source: nct_alias
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