Leukemia Clinical Trial
Official title:
Arsenic Trioxide Therapy for Interferon Alpha Refractory or Intolerant Chronic Phase Chronic Myelogenous Leukemia
Verified date | November 2018 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2002 |
Est. primary completion date | January 2002 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
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