CompletedPhase 1

Arsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma

United States, Australia, CanadaStarted 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 range

2 Years – 21 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00020111

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Leukemia trials

Who can participate

Age range

2 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.