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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. Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
2. Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, or Multiple Myeloma
3. Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia
4. Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
5. High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
Related Studies:
Other refractory chronic lymphocytic leukemia Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
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