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

• Status: Withdrawn
• Trial end date: 2002-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide

Criteria

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