Arsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma (NCT00020111) | Clinical Trial Compass
CompletedPhase 1
Arsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma
United StatesStarted 2000-03
Plain-language 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.
Who can participate
Age range2 Years – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 invest…