Clinical trial · Interventional
Arsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma
Phase I Trial and Pharmacokinetic Study of Arsenic Trioxide in Pediatric Patients With Refractory Leukemia or Lymphoma
NCT00020111CI-TRIAL-00017711completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTFox 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. PMID 17959855
- RESULTFox 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.