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Home > "D" Clinical Trials Conditions > Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia  Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
For Condition: refractory chronic lymphocytic leukemia,B-cell Chronic Lymphocytic Leukemia
Status: Recruiting
Sponsor(s): Comprehensive Cancer Center of Wake Forest University , National Cancer Institute (NCI)
Synopsis: RATIONALE: Denileukin diftitox may be able to deliver cancer-killing substances directly to leukemia cells. PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating patients who have fludarabine-refractoryB-cellchronic lymphocytic leukemia.
Details: OBJECTIVES: Primary - Determine the complete and partial response rate in patients with fludarabine-refractory B-cell chronic lymphocytic leukemia treated with denileukin diftitox. Secondary - Determine the toxicity profile of this drug in these patients. - Determine the response rate in patients (regardless of CD25 receptor density) treated with this drug. - Determine the progression-free survival and overall survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive denileukin diftitox IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response after 8 courses proceed to follow-up. Patients achieving a partial response or stable disease after 8 courses may continue treatment at the discretion of the investigator. Patients are followed every 3 months for 1 year and then annually until relapse. PROJECTED ACCRUAL: A total of 12-44 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria at any time during the course of disease (e.g., at initial diagnosis or relapse): - Absolute lymphocytosis > 5,000/mm^3 - Lymphocytes must appear mature with < 55% prolymphocytes - More than 30% of all nucleated cells are lymphoid on bone marrow aspirate smear - Lymphoid infiltrates compatible with bone marrow involvement by CLL on core bone marrow biopsy - Predominant B-cell monoclonal population of cells share the B-cell marker (CD19) with the CD5 antigen in the absence of other pan-T-cell markers by lymphocyte immunophenotyping - High-risk disease OR intermediate-risk disease - Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least 1 of the following criteria: - Massive or progressive splenomegaly and/or adenopathy - Weight loss > 10% within the past 6 months - Common toxicity grade 2-4 fatigue - Fevers > 100.5°F OR night sweats for more than 2 weeks without evidence of infection - Progressive lymphocytosis with an increase of > 50% over a 2-month period or an anticipated doubling time of < 6 months - Failed at least 1 prior fludarabine regimen, as defined by 1 of the following criteria: - Refractory or intolerant to fludarabine - Relapsed within 6 months after completion of fludarabine - No CNS leukemia - No mantle cell lymphoma in leukemic phase PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-2 Life expectancy - More than 2 months Hematopoietic - Absolute neutrophil count 1,000/mm^3 - Platelet count 50,000/mm^3 - Hemoglobin 8 g/dL (transfusion allowed) Hepatic - Albumin 3 g/dL - AST and ALT 2.5 times upper limit of normal (ULN) - Bilirubin 1.5 times ULN - No hepatitis B or C infection Renal - Creatinine 1.5 mg/dL OR - Creatinine clearance 40 mL/min Cardiovascular - LVEF 40% Other - No uncontrolled infection - No other concurrent serious illness - No HIV infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use two effective methods of contraception (one must be non-hormonal) during and for at least 1 month after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Prior denileukin diftitox allowed Chemotherapy - See Disease Characteristics Endocrine therapy - No concurrent corticosteroids as anti-emetics Radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - At least 28 days since prior anticancer therapy and recovered - No other concurrent antineoplastic drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ArthurFrankel, Study Chair, Comprehensive Cancer Center of Wake Forest University
Cancer Care Specialists *Recruiting*
Houma, Louisiana, 70360
United States
Recruiting Robert Gamble 985-857-8093
St. Joseph Hospital Regional Cancer Center - Orange *Recruiting*
Orange, California, 92868-3849
United States
Recruiting Leonard Sender 714-771-8042
Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130-3932
United States
Recruiting Francesco Turturro 318-675-8863
Maine General Medical Center - Waterville *Recruiting*
Waterville, Maine, 04901
United States
Recruiting Andrew Hertler 207-872-1140
Chattanooga Oncology and Hematology Associates *Recruiting*
Chattanooga, Tennessee, 37404
United States
Recruiting Edward Arrowsmith 423-698-1844
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Arthur Frankel 336-716-3313
Southwest Regional Cancer Center *Recruiting*
Austin, Texas, 78705
United States
Recruiting Robert Kerr 512-421-4100
University of Miami Sylvester Cancer Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Mark Goodman 305-243-4909
Southeastern Medical Oncology Center *Recruiting*
Goldsboro, North Carolina, 27534
United States
Recruiting Ernest Marshall 919-580-0000
Medical Center Vincennes *Recruiting*
Vincennes, Indiana, 47591
United States
Recruiting Donald Fleming 812-885-0680
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Phillip Kuriakose 313-916-9355
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Ronald Gartenhaus 312-503-1832
Additional Information:
Study ID Numbers: CDR0000361734; LIGAND-CCCWFU-27102,CCCWFU-BG02-331,CCCWFU-27102
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082940
Other Refractory Chronic Lymphocytic Leukemia Studies:
1. Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
2. 506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents
3. Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
4. Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia
5. Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia
Related Studies:
Other refractory chronic lymphocytic leukemia Clinical Trials
Other California Clinical Trials
Other Orange Clinical Trials
Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
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