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Home > "A" Clinical Trials Conditions > A Pilot Trial of CP-461 in Patients with Chronic Lymphocytic Leukemia  A Pilot Trial of CP-461 in Patients with Chronic Lymphocytic Leukemia
A Pilot Trial of CP-461 in Patients with Chronic Lymphocytic Leukemia
For Condition: Leukemia,Chronic Lymphocytic Leukemia
Status: No longer recruiting
Sponsor(s): OSI Pharmaceuticals ,
Synopsis: The purpose of this study is to determine the activity of CP-461 in previously untreated Chronic Lymphocytic Leukemia (CLL) patients. The safety profile of CP-461 in this patient population will also be evaluated.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1. Diagnosis of CLL established by bone marrow aspiration and biopsy or flow cytometry of peripheral blood. Patients must have at least 1 of the following: a. a rising lymphocyte count with a doubling time of the lymphocyte count less than 12 months and an absolute lymphocyte count greater than 20,000/uL, or b. an absolute lymphocyte count greater than 80,000/uL, or c. radiographically measurable disease. 2. No previous therapy for CLL. 3. Expected remaining life span > or = six months. 4. ECOG Performance Status (PS) 0–2. 5. Platelet count > or = 100,000/mm3 , hemoglobin > or = 10 gm/dL. 6. 18 years or older. 7. If female of childbearing potential, serum pregnancy test is negative. 8. If fertile (male or female), the patient agrees to use acceptable methods to avoid pregnancy for the duration of the study. 9. Willingness and ability to sign an informed consent. Exclusion Criteria: 1. Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years. 2. History of other malignancy which could affect the diagnosis or assessment of CP-461. 3. Previous therapy for CLL. 4. Patients with small lymphocytic lymphoma without absolute lymphocytosis >5000/uL. 5. Use of an investigational medication or device within 1 month of initiating study therapy. 6. Concurrent immunotherapy. 7. Use of steroids at the time of enrollment (Patients who require steroids after enrollment may remain on study). 8. Total serum bilirubin above the upper limit of normal; or serum creatinine above the upper limit of normal. Patients with elevated indirect bilirubin due to Gilbert’s syndrome will be eligible. 9. AST or ALT > 1.5 times the upper limit of normal. 10. Any condition or any medication which may interfere with the conduct of the study. 11. Serious uncontrolled intercurrent medical or psychiatric illness, including serious infection. 12. Evidence of CNS involvement. 13. Pregnant or nursing women.
Total Enrollment: 23
Location and Contact Information:
Iowa Oncology Associates
Cedar Rapids, Iowa, 52403
United States
Hematology and Oncology Associates of Jacksonville
Jacksonville, Florida, 32207
United States
Dayton Oncology/Hematology Consultants
Dayton, Ohio, 45439
United States
Oncology/Hematology Associates of Kansas City
Kansas City, Missouri, 64111
United States
Tyler Cancer Center
Tyler, Texas, 75702
United States
Hematology Oncology Associates of South Texas
San Antonio, Texas, 78229
United States
Oncology and Hematology Associates of Southwest Virginia
Roanoke, Virginia, 24101
United States
Arizona Hematology and Oncology Associates
Phoenix, Arizona, 85012
United States
Williamette Valley Cancer Center
Eugene, Oregon, 97401
United States
Central Texas Oncology Associates
Austin, Texas, 78705
United States
Cancer Centers of the Carolinas - Eastside
Greenville, South Carolina, 29615
United States
Ocala Oncology Center
Ocala, Florida, 34474
United States
Cancer Care Northwest
Spokane, Washington, 99202
United States
Triad Hematology and Oncology Associates
Winston Salem, North Carolina, 27103
United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
United States
Additional Information:
Study ID Numbers: CP 461-005;
Study Start Date: June 2001
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036049
Other Leukemia Studies:
1. Donor Th2 Cells to Prevent Graft-Versus-Host Disease in Bone Marrow Transplants
2. Genasenseâ„¢ (Oblimersen Sodium), Fludarabine, and Rituximab in Subjects with Chronic Lymphocytic Leukemia
3. Phase I Study of Anti-Tac(Fv)-PE38 (LMB-2), a Recombinant Single-Chain Immunotoxin for Treatment of Tac-Expressing Malignancies
4. Campath-1H Plus Rituximab for CD52- and CD20- Positive Refractory or Relapsed Chronic Lymphoid Disorders
5. BMS-247550 in Treating Patients With Relapsed or Refractory Low-Grade Lymphoproliferative Disorders
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A Pilot Trial of CP-461 in Patients with Chronic Lymphocytic Leukemia
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