Acute Myeloid Leukemia Clinical Trial

Arsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.

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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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Study ID:

NCT00020111

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 51 Locations for this study

See Locations Near You

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla California, 92103, United States
Children's Hospital Los Angeles
Los Angeles California, 90027, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
Children's Hospital of Orange County
Orange California, 92868, United States
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto California, 94304, United States
UCSF Comprehensive Cancer Center
San Francisco California, 94143, United States
County of Los Angeles Harbor-UCLA Medical Center
Torrance California, 90509, United States
Children's National Medical Center
Washington District of Columbia, 20010, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
Atlanta Georgia, 30342, United States
Children's Memorial Hospital - Chicago
Chicago Illinois, 60614, United States
Riley Children Cancer Center at Riley Hospital for Children
Indianapolis Indiana, 46202, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda Maryland, 20892, United States
Floating Hospital for Children
Boston Massachusetts, 02111, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Children's Hospital of Michigan
Detroit Michigan, 48201, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Children's Mercy Hospital
Kansas City Missouri, 64108, United States
Cardinal Glennon Children's Hospital
Saint Louis Missouri, 63104, United States
St. Louis Children's Hospital
Saint Louis Missouri, 63110, United States
Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York New York, 10032, United States
SUNY Upstate Medical University Hospital
Syracuse New York, 13210, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland Ohio, 44106, United States
Oklahoma University Medical Center
Oklahoma City Oklahoma, 73126, United States
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh Pennsylvania, 15213, United States
St. Jude Children's Research Hospital
Memphis Tennessee, 38105, United States
Vanderbilt Children's Hospital
Nashville Tennessee, 37232, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas Texas, 75390, United States
Cook Children's Medical Center - Fort Worth
Fort Worth Texas, 76104, United States
Texas Children's Cancer Center
Houston Texas, 77030, United States
MD Anderson Cancer Center at University of Texas
Houston Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City Utah, 84112, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle Washington, 98105, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Midwest Children's Cancer Center
Milwaukee Wisconsin, 53226, United States
Royal Children's Hospital
Parkville Victoria, 3052, Australia
Princess Margaret Hospital for Children
Perth Western Australia, 6001, Australia
Hospital for Sick Children
Toronto Ontario, M5G 1, Canada
Montreal Children's Hospital at McGill University Health Center
Montreal Quebec, H3H 1, Canada
Hopital Sainte Justine
Montreal Quebec, H3T 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Study ID:

NCT00020111

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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