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Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia Clinical research trials and Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia. Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia clinical trial. Subjects often receive the most expert healthcare possible for their Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia  Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia
Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia
For Condition: B-cell Chronic Lymphocytic Leukemia,refractory chronic lymphocytic leukemia
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have chronic lymphocytic leukemia that has relapsed or has not responded to treatment with fludarabine.
Details: OBJECTIVES: I. Determine the clinical efficacy and safety of arsenic trioxide in patients with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine or in relapse. II. Determine the pattern of clinical adverse experience in these patients when treated with this regimen. III. Evaluate the effects of this drug on cytokines, apoptosis, and angiogenesis in these patients. PROTOCOL OUTLINE: Patients receive arsenic trioxide IV over 2 hours on days 1-15 OR on days 1-5, 8-12, and 15-19. Courses repeat with 2 to 5 week intervals between courses for 10-12 courses (about 1 year) in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 6 months for the second year, and then annually thereafter. PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Relapsed or refractory chronic lymphocytic leukemia (CLL); Previously treated with alkylating agent; Refractory or intolerant to fludarabine as defined by: Progressive disease during treatment with fludarabine; Stable disease (no partial or complete response) after at least 2 courses of fludarabine; Relapse or progressive disease within 6 months of treatment with fludarabine; Autoimmune hemolytic anemia or idiopathic thrombocytopenia concurrent with or within 1 month after completion of fludarabine; Grade 2 pulmonary toxicity or neurotoxicity that would preclude further treatment with fludarabine OR Progressive B-cell CLL as defined by at least 1 of the following: Hemoglobin less than 11 g/dL, or progressive decline; Platelet count no greater than 100,000/mm3, or progressive decline; Massive (greater than 6 cm below costal margin) or progressive splenomegaly; Massive lymph nodes or clusters or progressive lymphadenopathy; At least 10% weight loss in past 6 months; Fatigue grade 2-3; Fever (greater than 100.5 F) or night sweats for greater than 2 weeks without evidence of infection Progressive lymphocytosis greater than 50% over 2 month period, or anticipated doubling time less than 6 months; Lymphocyte count greater than 100,000/mm3 - No uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia - No other uncontrolled immune phenomena related to CLL - No CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent stem cell transplant - Chemotherapy: See Disease Characteristics; At least 14 days since prior chemotherapy and recovered (unless evidence of disease progression); No concurrent chemotherapy No prior arsenic treatment - Endocrine therapy: No concurrent steroidal or hormonal therapy for cancer; Steroids for adrenal failures and hormones for nondisease conditions allowed - Radiotherapy: At least 14 days since prior radiotherapy and recovered (unless evidence of disease progression); No concurrent radiotherapy - Other: At least 14 days since other investigational agents and recovered (unless evidence of disease progression); No concurrent other investigational agents --Patient Characteristics-- - Age: 12 and over - Performance status: Zubrod 0-2 - Life expectancy: At least 2 years - Hematopoietic: See Disease Characteristics - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's disease or direct CLL infiltration of liver); SGOT or SGPT no greater than 2.5 times ULN (unless due to direct CLL infiltration of liver); No hepatic disease that would preclude study - Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min - Cardiovascular: No unstable angina pectoris; No cardiac arrhythmia; No prior grade III or IV New York Heart Association cardiac problem; No cardiovascular disease that would preclude study - Other: No prior grand mal seizures (infantile febrile seizures allowed); No other active malignancy; No other uncontrolled concurrent medical problem; No active uncontrolled infection; No prior hypersensitivity to arsenic trioxide or related drugs; No neurologic, endocrine, or other systemic disease that would preclude study; No other condition that would preclude study compliance; Not pregnant or nursing Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeborahThomas, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000068092; MDA-DM-00059,NCI-310
Study Start Date: June 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006090
Other Refractory Chronic Lymphocytic Leukemia Studies:
1. Chlorambucil in Treating Patients With Advanced Chronic Lymphocytic Leukemia
2. Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia
3. Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia
4. Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
5. Fludarabine and Cyclophosphamide With or Without Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Related Studies:
Other refractory chronic lymphocytic leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia
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