Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia
NCT ID: NCT00006092
Last Updated: 2012-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
2 participants
INTERVENTIONAL
2000-08-31
2003-03-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arsenic Trioxide Treatment
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.
Arsenic Trioxide
Interventions
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Arsenic Trioxide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Thomas P. Loughran, MD
Role: STUDY_CHAIR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Countries
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Other Identifiers
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NCI-1230
Identifier Type: OTHER
Identifier Source: secondary_id
MCC-12395
Identifier Type: -
Identifier Source: org_study_id