Study Evaluating Effects of CX-3543 in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

This study has been withdrawn prior to enrollment.
(This study was withdrawn prior to patient enrollment)
Sponsor:
Information provided by:
Cylene Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00485966
First received: June 11, 2007
Last updated: November 3, 2008
Last verified: November 2008
  Purpose

This is a Phase 2, open-label, multicenter, efficacy, safety, and pharmacodynamic study of CX-3543 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL).


Condition Intervention Phase
B-Cell Chronic Lymphocytic Leukemia
Drug: CX-3543
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Open Label Study Evaluating Clinical Efficacy, Safety, and Pharmacodynamic Effects of Quarfloxacin (CX-3543) in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Resource links provided by NLM:


Further study details as provided by Cylene Pharmaceuticals:

Primary Outcome Measures:
  • Efficacy
  • Safety

Secondary Outcome Measures:
  • Clinical benefit
  • Pharmacodynamics
  • Study drug blood levels
  • Progression free survival

Estimated Enrollment: 25
Study Start Date: June 2007
Estimated Study Completion Date: June 2008
Intervention Details:
    Drug: CX-3543
    360 mg/m2 daily x 5 q 21 days
Detailed Description:

The purpose of this trial is to evaluate the response rate, safety, pharmacodynamic effects, and duration of response of CX-3543 in patients with relapsed or refractory B-cell CLL.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with B-cell CLL with indications for treatment by National Cancer Institute (NCI) Working Group 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:

  • Pregnant or nursing women.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485966

Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-0001
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239-3098
United States, Texas
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
United States, Wisconsin
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Cylene Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00485966     History of Changes
Other Study ID Numbers: C3-07-001
Study First Received: June 11, 2007
Last Updated: November 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Cylene Pharmaceuticals:
Adult Leukemia
CLL
B-CLL
Chronic Lymphocytic Leukemia
B-cell CLL

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on September 16, 2014