Study Evaluating Effects of CX-3543 in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
NCT ID: NCT00485966
Last Updated: 2008-11-05
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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WITHDRAWN
PHASE2
25 participants
INTERVENTIONAL
2007-06-30
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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CX-3543
360 mg/m2 daily x 5 q 21 days
Eligibility Criteria
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Inclusion Criteria
* Measurable disease (lymphocytes ≥ 5,000/microliter, or palpable lymphadenopathy or bone marrow involvement \> 30%).
* Males and females 18 years of age or older.
* Received a minimum of one prior purine analog-based chemotherapy regimen (e.g., fludarabine, cladribine, or pentostatin) and one monoclonal antibody therapy (e.g., Campath or Rituxan) but ≤ 4 chemotherapy regimens.
* Patients must have central intravenous (IV) access, or agree to the insertion of a central line.
* All previous cancer therapies, radiation, hormonal therapy and surgery, must have been discontinued at least 28 days prior to the start of treatment. Any cytotoxic chemotherapy must have been discontinued 28 days prior to the start of treatment. Acute toxicities from prior therapy must have resolved to Grade ≤ 1 above baseline.
* Normal oxygen saturation with pulse oximetry on room air.
* Hemoglobin ≥ 9 gm/dL (may be post-transfusion).
* Platelet count ≥ 25,000/microliter.
* Total bilirubin \< 2 X upper limit of normal (ULN), and ALT and AST \< 2 x ULN.
* Serum creatinine within normal limits OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above the upper normal limit for the institution
* ECOG Performance Status ≤ 1.
* Anticipated survival of at least 3 months.
* For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after discontinuation of treatment.
* Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return to the clinic for required assessments.
Exclusion Criteria
* Severe chronic obstructive pulmonary disease with hypoxemia or an uncorrectable pulmonary compromise.
* Seizures not controlled by anticonvulsant therapy.
* Participation in any investigational drug study within 28 days before quarfloxacin administration.
* Patients with second malignancy requiring active treatment.
* Active symptomatic bacterial, fungal, or viral infection including active HIV or viral (A, B, or C) hepatitis.
* Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
* Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones) or formulation (containing buffers and/or polyethylene glycol).
* Patients with life- or function-threatening CLL complications (e.g., cord compression, hemolytic crisis, urinary tract obstruction).
* Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.
18 Years
ALL
No
Sponsors
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Cylene Pharmaceuticals
INDUSTRY
Locations
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Mayo Clinic
Scottsdale, Arizona, United States
Tower Cancer Research Foundation
Beverly Hills, California, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Oregon Health and Sciences University
Portland, Oregon, United States
Cancer Therapy and Research Center
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Countries
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Other Identifiers
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C3-07-001
Identifier Type: -
Identifier Source: org_study_id