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Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia Clinical research trials and Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia health trials happen in many 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 measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia. Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia clinical trial. Human subjects often get the best healthcare available for their Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia  Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia
Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia
For Condition: untreated adult acute myeloid leukemia,adult acute myeloblastic leukemia without maturation (M1),adult acute megakaryocytic leukemia (M7),adult acute minimally differentiated myeloid leukemia (M0),adult acute poorly differentiated monocytic leukemia (M5a),adult acute myelomonocytic leukemia (M4),adult acute myeloblastic leukemia with maturation (M2),adult acute differentiated monocytic leukemia (M5b),secondary acute myeloid leukemia,recurrent adult acute myeloid leukemia,adult acute erythroleukemia (M6)
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Robert H. Lurie 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 acute myeloid leukemia.
Details: OBJECTIVES: I. Determine the rate of response (complete or partial remission), duration of response, relapse free survival, and overall survival of patients with relapsed or refractory acute myeloid leukemia (AML) or untreated older patients or those with secondary AML when treated with arsenic trioxide. II. Evaluate the toxicities of this agent in this patient population. III. Measure degree of apoptosis induced and/or differentiation in pretreatment and posttreatment AML cells. PROTOCOL OUTLINE: Patients receive arsenic trioxide IV over 1-4 hours daily for up to 60 days, or until bone marrow blasts are less than 5%, followed by 4-6 weeks of rest. After the first course, additional courses of arsenic trioxide last 25 days. Treatment continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 1 additional 25 day course after achieving CR. Patients are followed monthly for 6 months, every 2 months for 6 months, every 3 months for 12 months, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Documented acute myelogenous leukemia (AML) including secondary AML and biphenotypic leukemia; Secondary AML may be either chemotherapy induced or evolving from a myelodysplastic syndrome - Bone marrow evidence of AML must include the following: Cellularity of 20% or greater Minimum of 20% leukemic cells Signs of bone marrow failure such as: Anemia (hemoglobin less than 12.0 g/dL); Granulocytopenia (granulocyte count less than 1,500/mm3); Thrombocytopenia (platelet count less than 100,000/mm3) - Must not be any of the following: Acute lymphoblastic leukemia; Blastic phase of chronic myelogenous leukemia; Acute promyelocytic leukemia (M3) - Prior induction therapy using any conventional induction chemotherapy regimen required; In first or second relapse after successful induction therapy OR Failed 1 attempt at reinduction relapse OR Refractory to at least 1 prior induction therapy - No prior induction therapy allowed in secondary AML or in newly diagnosed AML in patients at least 65 years old --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent bone marrow transplantation - Chemotherapy: See Disease Characteristics; At least 3 weeks since prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No concurrent radiotherapy - Surgery: Not specified - Other: No other concurrent antileukemic agents --Patient Characteristics-- - Age: 16 and over - Performance status: ECOG 0-2 - Life expectancy: At least 6 weeks - Hematopoietic: See Disease Characteristics; No evidence of being platelet transfusion refractory; WBC no greater than 20,000/mm3 (leukapheresis, hydroxyurea, or both allowed) - Hepatic: Bilirubin no greater than 2.0 mg/dL unless leukemic infiltration to liver; SGOT or SGPT less than 2 times upper limit of normal - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No evidence of symptomatic coronary atherosclerotic heart disease - Other: Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception; No active infection and afebrile; Afebrile, stable, and completing antibiotics allowed; Febrile not from infection but from blood products allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MartinTallman, Study Chair, Robert H. Lurie Cancer Center
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Additional Information:
Study ID Numbers: CDR0000067756; NU-99H6,NU-476-016,NCI-T99-0094
Study Start Date: February 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005795
Other Adult Acute Erythroleukemia (m6) Studies:
1. DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia
2. Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia
3. Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia
4. Liposomal Daunorubicin and SU5416 in Treating Patients With Hematologic Cancer That Has Not Responded to Initial Therapy
5. Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia After Stem Cell Transplantation
Related Studies:
Other adult acute erythroleukemia (M6) Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia
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