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Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment Clinical research trials and Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment. Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment clinical trial. Subjects frequently obtain the most expert healthcare possible for their Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment  Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment
Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment
For Condition: refractory chronic myelogenous leukemia,chronic phase chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous 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 cancer 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 phase chronic myelogenous leukemia that has not responded to previous treatment.
Details: OBJECTIVES: I. Determine the rate of complete or major cytogenetic response to arsenic trioxide as demonstrated by a decrease in the percentage of Philadelphia chromosome positive (or breakpoint cluster region bcr positive) cells in the bone marrow in patients with interferon alfa refractory or intolerant chronic phase chronic myelogenous leukemia. II. Determine the rate and duration of complete hematological response to this treatment in these patients. III. Determine the duration of complete and major cytogenetic response to this treatment in these patients. IV. Determine the pattern of clinical adverse experience and improvement in symptomatic parameters with this treatment in these patients. V. Determine the time to accelerated disease or blast crisis and overall survival in these patients after receiving this treatment. VI. Determine the effects of this treatment on cytokines, apoptosis, and angiogenesis in these patients. PROTOCOL OUTLINE: Patients receive arsenic trioxide IV over 2 hours either daily for 15 consecutive days or 5 days on, 2 days off for a total of 15 doses. Treatment repeats every 2-5 weeks after the previous course for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission are followed every month for 3 months, every 2 months for 6 months, every 3-4 months for 1 year, and then every 6 months thereafter. All other patients are followed every 3 months for 1 year and then annually thereafter. PROJECTED ACCRUAL: A total of 17-53 patients will be accrued for this study within 2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of Philadelphia (Ph) chromosome positive (or breakpoint cluster region bcr positive) chronic myelogenous leukemia in chronic phase - Ineligible for or refused allogeneic bone marrow transplantation - Interferon alfa refractory or intolerant as defined by the following: Refractory: Failure to achieve a complete hematologic response lasting for at least 1 month after prior therapy with interferon alfa based regimen for at least 3 months 65% or more; Ph positive chromosomes in bone marrow after one year of interferon alfa based therapy; At least a 30% increase in Ph positive chromosomes in bone marrow in samples taken at least one month apart OR An increase of at least 65% in Ph positive chromosomes in bone marrow; Intolerant: Grade 3 or greater nonhematologic toxicity Autoimmune phenomenon at any grade - No accelerated phase or blastic phase disease as defined by the following: Greater than 15% blasts or basophils in the peripheral blood or bone marrow; Greater than 30% blasts plus promyelocytes in the peripheral blood or bone marrow; Documented extramedullary blastic disease outside liver or spleen; Platelet count less than 100,000/mm3 unrelated to therapy; Clonal evolution (additional chromosomal abnormalities other than Ph chromosome) as solitary feature is not considered accelerated disease - No known brain metastases or CNS disease --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; No concurrent bone marrow or peripheral blood stem cell transplantation - Chemotherapy: At least 14 days since prior chemotherapy (48 hours for hydroxyurea and 6 weeks for busulfan) and recovered (unless evidence of rapidly progressive disease); No other concurrent cytotoxic chemotherapy; No prior arsenic trioxide - Endocrine therapy: No concurrent steroids for the treatment of neoplasms (except for new adrenal failures); No concurrent hormones for the treatment of neoplasms (except for nondisease related conditions) - Radiotherapy: At least 14 days since prior radiotherapy; No concurrent radiotherapy - Surgery: Not specified - Other: At least 14 days since other prior investigational agent; No other concurrent investigational or antileukemic agents --Patient Characteristics-- - Age: 12 and over - Performance status: Zubrod 0-2 - Life expectancy: At least 2 years - Hematopoietic: See Disease Characteristics - Hepatic: Unless due to direct disease infiltration of the liver: ALT and AST no greater than 2.5 times upper limit of normal (ULN); Bilirubin no greater than 1.5 times ULN (unless due to Gilbert's disease); No hepatic disease that would preclude study - Renal: Creatinine no greater than 1.5 times ULN; Creatinine clearance at least 60 mL/min - Cardiovascular: No history of New York Heart Association grade III or IV cardiac disease; No cardiovascular disease that would preclude study; No unstable angina pectoris or cardiac arrhythmia that would shorten life expectancy - Other: No history of grand mal seizures other than infantile febrile seizures; No active secondary malignancy or other uncontrolled concurrent medical problem that would shorten life expectancy; No neurologic, endocrine, or other major systemic disease that would preclude study; No active infection uncontrolled by oral or IV antibiotics; No history of hypersensitivity to the study drug or drugs with similar chemical structure; No mental condition that would preclude study; 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: CDR0000068094; MDA-DM-00058,NCI-311
Study Start Date: June 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006091
Other Refractory Chronic Myelogenous Leukemia Studies:
1. Sargramostim Following Allogeneic Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia
2. Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase
3. Imatinib Mesylate and Cytarabine in Treating Patients With Newly Diagnosed Chronic Myeloid Leukemia
4. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Chronic Myelogenous Leukemia
5. Chemotherapy, Biological Therapy, and/or Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
Related Studies:
Other refractory chronic myelogenous leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment
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