Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment

NCT00006091 | Withdrawn Phase 2

• 4 other identifiers: CDR0000068094MDA-DM-00058NCI-311ID00-058
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 chronic phase chronic myelogenous leukemia that has not responded to previous treatment.

Conditions

Leukemia

Keywords

relapsing chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; chronic myelogenous leukemia, BCR-ABL1 positive

Interventions

arsenic trioxide DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of Philadelphia (Ph) chromosome positive (or breakpoint cluster region bcr positive) chronic myelogenous leukemia in chronic phase * Ineligible for or refused allogeneic bone marrow transplantation * Interferon alfa refractory or intolerant as defined by the following: * Refractory: Failure to achieve a complete hematologic response lasting for at least 1 month after prior therapy with interferon alfa based regimen for at least 3 months 65% or more Ph positive chromosomes in bone marrow after one year of interferon alfa based therapy * At least a 30% increase in Ph positive chromosomes in bone marrow in samples taken at least one month apart OR * An increase of at least 65% in Ph positive chromosomes in bone marrow * Intolerant: Grade 3 or greater nonhematologic toxicity Autoimmune phenomenon at any grade * No accelerated phase or blastic phase disease as defined by the following: * Greater than 15% blasts or basophils in the peripheral blood or bone marrow * Greater than 30% blasts plus promyelocytes in the peripheral blood or bone marrow * Documented extramedullary blastic disease outside liver or spleen * Platelet count less than 100,000/mm3 unrelated to therapy * Clonal evolution (additional chromosomal abnormalities other than Ph chromosome) as solitary feature is not considered accelerated disease * No known brain metastases or central nervous system (CNS) disease PATIENT CHARACTERISTICS: * Age: 12 and over * Performance status: Zubrod 0-2 * Life expectancy: At least 2 years * Hematopoietic: See Disease Characteristics * Hepatic: Unless due to direct disease infiltration of the liver: * ALT and AST no greater than 2.5 times upper limit of normal (ULN) * Bilirubin no greater than 1.5 times ULN (unless due to Gilbert's disease) * No hepatic disease that would preclude study * Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at least 60 mL/min * Cardiovascular: No history of New York Heart Association grade III or IV cardiac disease * No cardiovascular disease that would preclude study * No unstable angina pectoris or cardiac arrhythmia that would shorten life expectancy * Other: No history of grand mal seizures other than infantile febrile seizures * No active secondary malignancy or other uncontrolled concurrent medical problem that would shorten life expectancy * No neurologic, endocrine, or other major systemic disease that would preclude study * No active infection uncontrolled by oral or IV antibiotics * No history of hypersensitivity to the study drug or drugs with similar chemical structure * No mental condition that would preclude study Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * Biologic therapy: See Disease Characteristics * No concurrent bone marrow or peripheral blood stem cell transplantation * Chemotherapy: At least 14 days since prior chemotherapy (48 hours for hydroxyurea and 6 weeks for busulfan) and recovered (unless evidence of rapidly progressive disease) * No other concurrent cytotoxic chemotherapy * No prior arsenic trioxide * Endocrine therapy: No concurrent steroids for the treatment of neoplasms (except for new adrenal failures) * No concurrent hormones for the treatment of neoplasms (except for nondisease related conditions) * Radiotherapy: At least 14 days since prior radiotherapy * No concurrent radiotherapy * Surgery: Not specified * Other: At least 14 days since other prior investigational agent * No other concurrent investigational or antileukemic agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Deborah A. Thomas, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2000
• First Posted: March 16, 2004
• Study Start: June 19, 2000
• Primary Completion: January 1, 2002
• Study Completion: January 1, 2002
• Last Updated: November 14, 2018

Record last verified: 2018-11