Expired Study
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Tampa, Florida 33612


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00006092


Primary Contact:

Study Chair
Thomas P. Loughran, MD
H. Lee Moffitt Cancer Center and Research Institute


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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