Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia

Phase 2TerminatedNCT00006092

H. Lee Moffitt Cancer Center and Research Institute2 enrolled

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia.

OBJECTIVES: * Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide. * Determine the duration of hematologic response and overall survival of these patients when treated with this regimen. * Determine the pattern of clinical adverse experience in these patients when treated with this regimen. * Determine the pharmacokinetic profile of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course. Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 24-49 patients will be accrued for this study within 2.5 years.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia

Interventions

Arsenic TrioxideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosis of one of the following: * Acute lymphoblastic leukemia * Philadelphia chromosome (Bcr-abl) positive * Refractory to initial therapy OR recurrent following 1 induction therapy regimen with or without consolidation therapy and/or bone marrow transplantation * Blastic phase chronic myelogenous leukemia * Philadelphia chromosome (Bcr-abl) positive * Previously untreated OR recurrent or refractory following 1 induction therapy regimen with or without consolidation therapy including imatinib mesylate * Must not be eligible for bone marrow transplant PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: * At least 8 weeks Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2.0 times upper limit of normal (ULN) * AST/ALT no greater than 2 times ULN Renal: * Creatinine no greater than 2.0 times ULN * Creatinine clearance greater than 70 mL/min Cardiovascular: * No uncontrolled angina * No New York Heart Association class III or IV heart disease * No second degree heart block without pacemaker Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study * HIV negative * No uncontrolled infection or other serious concurrent illness * No peripheral neuropathy * No potassium less than 3.0 or greater than 5.5 mEq/L that can not be corrected OR * No magnesium less than 1.2 or greater than 2.5 mEq/L that can not be corrected * Electrolyte imbalances must be corrected prior to study entry PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics * At least 28 days since prior chemotherapy * At least 24 hours since prior hydroxyurea * No prior arsenic trioxide * No other concurrent cytotoxic chemotherapy except intrathecal chemotherapy for CNS leukemia Endocrine therapy: * Not specified Radiotherapy: * At least 28 days since prior radiotherapy * No concurrent radiotherapy including for palliation Surgery: * Not specified Other: * At least 14 days since prior imatinib mesylate * No other concurrent investigational agents * No concurrent amphotericin B

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Outcomes

Primary Outcomes

Objective Rate of Response (ORR)

Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide.

Time frame: 2.5 years

Data from ClinicalTrials.gov

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