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506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on 506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. 506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents Clinical research trials and 506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like 506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents. 506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a 506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents clinical trial. Human subjects often obtain the finest healthcare possible for their 506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "5" Clinical Trials Conditions > 506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents  506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents
506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents
For Condition: B-cell Chronic Lymphocytic Leukemia,refractory chronic lymphocytic leukemia,T-cell chronic lymphocytic leukemia
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , GlaxoSmithKline
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients with chronic lymphocytic leukemia that has not responded to fludarabine or alkylating agents.
Details: OBJECTIVES: I. Estimate the anticancer efficacy of 506U78 in patients with chronic lymphocytic leukemia who are refractory to fludarabine and alkylator therapy. II. Define the safety (including incidence of infection) of 506U78 in these patients. III. Evaluate the pharmacokinetics of 506U78 and ara-G, and assess the intracellular pharmacokinetics of ara-GTP in patients receiving multiple treatment courses (at M.D. Anderson Cancer Center only). IV. Determine the response rate, time to maximal response, and duration of response of patients treated with this drug. V. Determine two-year survival rate and progression-free survival of patients treated with this drug. PROTOCOL OUTLINE: This is an open-label, multicenter study. Patients are stratified according to cellular type of disease (B-CLL vs T-CLL). Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Courses are repeated every 28 days. Treatment continues for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days after the final course and then every 2 months for 2 years until disease progression. Patients with progressive disease are followed for survival every 3 months for 2 years or until death. PROJECTED ACCRUAL: Approximately 14-100 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven refractory B-cell or T-cell chronic lymphocytic leukemia; Evidence of active disease following fludarabine or alkylator therapy - Must meet one or more of the following criteria for active disease: Minimum of one of the following disease-related symptoms: Weight loss of more than 10% within the previous 6 months; Extreme fatigue (e.g., unable to work or perform usual activities); Fevers greater than 100.5 degrees F for 2 weeks or more without evidence of infection; Night sweats without evidence of infection; Evidence of progressive marrow failure manifested by the development of, or worsening of autoimmune anemia and /or thrombocytopenia that is poorly responsive to corticosteroid therapy; Massive nodes or clusters (e.g., greater than 10 cm in longest diameter) or progressive lymphadenopathy; Progressive lymphocytosis with an increase of greater than 50% over a 2-month period or an anticipated doubling time of less than 6 months - Ineligible if marked hypogammaglobulinemia or development of monoclonal protein in the absence of the above criteria for active disease - Must have one of the following resulting from prior fludarabine or alkylator-containing therapy: Disease progression during therapy OR Failure to respond or obtained less than a partial response to therapy OR Disease progression within 6 months of the last course of therapy following and initial response; Failure to respond or disease progression allowed at any time following the final course if alkylator agent was not the most recent therapy - Must have adequate hepatic and renal function; No liver dysfunction due to organ infiltration by lymphocytes --Prior/Concurrent Therapy-- - Biologic therapy: No prior bone marrow or peripheral stem cell transplantation; At least 4 weeks since prior biologic therapy and recovered Concurrent growth factors allowed - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered; No prior 506U78 therapy; No other concurrent chemotherapy - Endocrine therapy: No concurrent corticosteroid therapy greater than 10 mg/day of prednisone equivalent; No concurrent corticosteroids as antiemetics; Concurrent hormone replacement therapy or oral contraceptives allowed; Concurrent hydrocortisone as prophylaxis or treatment of transfusion reactions allowed - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; No concurrent radiotherapy - Surgery: Not specified - Other: No other concurrent anticancer agents --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: At least 12 weeks - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than 2 times upper limit of normal - Renal: Creatinine clearance at least 50 mL/min - Neurologic: No neurotoxicity of grade 2 or higher Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for up to 28 days after study; No history of seizure disorder; No active infection; No other malignancy within the past 2 years (except adequately treated non- melanomatous skin cancer or carcinoma in situ) that would preclude study; No systemic nonmalignant comorbid disease that would preclude study; No psychological, sociological, or geographical condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TonyaPeele, Study Chair, GlaxoSmithKline
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-2410
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Sidney Kimmel Cancer Center
San Diego, California, 92121
United States
Clinical Studies, Ltd.
Denver, Colorado, 80222
United States
Medicine Branch
Bethesda, Maryland, 20892
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Physician Reliance Network, Inc.
Dallas, Texas, 75246
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Greenville Hospital System
Greenville, South Carolina, 29605
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Scripps Clinic
La Jolla, California, 92037
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Additional Information:
Study ID Numbers: CDR0000066719; GW-PGAA2003,CWRU-GLAX-1999,MB-405,NCI-98-C-0164,UCLA-991004701A
Study Start Date: January 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003635
Other B-Cell Chronic Lymphocytic Leukemia Studies:
1. Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia
2. 506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents
Related Studies:
Other B-cell Chronic Lymphocytic Leukemia Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents
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