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Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia Clinical research trials and Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia. Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia clinical trial. Participants frequently get the best healthcare available for their Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia  Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia
Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia
For Condition: adult acute differentiated monocytic leukemia (M5b),adult acute erythroleukemia (M6),adult acute megakaryocytic leukemia (M7),untreated adult acute myeloid leukemia,adult acute myeloblastic leukemia without maturation (M1),childhood acute myeloblastic leukemia without maturation (M1),adult acute myelomonocytic leukemia (M4),childhood acute differentiated monocytic leukemia (M5b),adult acute myeloblastic leukemia with maturation (M2),adult acute poorly differentiated monocytic leukemia (M5a),childhood acute megakaryocytic leukemia (M7),untreated childhood acute myeloid leukemia,childhood acute poorly differentiated monocytic leukemia (M5a),childhood acute erythroleukemia (M6),childhood acute myelomonocytic leukemia (M4),childhood acute myeloblastic leukemia with maturation (M2)
Status: No longer recruiting
Sponsor(s): Rush Cancer Institute at Rush University Medical Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Combining more than one chemotherapy drug with biological therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, isotretinoin, and interferon alfa in treating patients who have acute myelogenous leukemia.
Details: OBJECTIVES: I. Assess the efficacy of high dose cytarabine with mitoxantrone and amifostine as induction therapy for patients with previously untreated standard risk acute myelogenous leukemia (AML). II. Assess the effects of amifostine on the biology of AML cells in vivo in these patients. III. Determine whether there is a relationship between cytokine production before and during remission induction therapy and treatment outcome. PROTOCOL OUTLINE: Prior to treatment, patients undergo bone marrow aspirate and biopsy. On day -3, patients receive idoxuridine IV over 60 minutes followed immediately by a bone marrow aspirate and biopsy. Patients then receive amifostine IV over 5-7 minutes on the same day. Prior to chemotherapy on day 1, patient receive broxuridine IV over 60 minutes immediately followed by bone marrow aspirate and biopsy. Chemotherapy on day 1 consists of amifostine followed by cytarabine IV over 3 hours repeated every 12 hours and mitoxantrone IV over 1 hour immediately after the second infusion of cytarabine. This course is repeated on day 5 after another bone marrow biopsy and aspirate. Starting on day 6, patients receive amifostine 3 times a week until day 28 or beyond. Patients who respond to treatment continue on to receive three courses of consolidation therapy. Consolidation courses 1 and 3 consist of cytarabine continuous IV on days 1-7 and idarubicin IV over 30 minutes on days 1, 2, and 3. Consolidation course 2 consists of cytarabine IV over 75 minutes repeated every 12 hours for 4 days. Twenty-four hours after each course of consolidation therapy, patients receive isotretinoin orally every day and interferon alfa subcutaneously every other day. Isotretinoin and interferon alfa therapy are stopped 4 days prior to day 1 of the next course of consolidation therapy. Following recovery from course 3 of consolidation therapy, patients continue to receive isotretinoin/interferon alfa until relapse. Patients in complete remission after the 3 courses of consolidation therapy receive isotretinoin/interferon alfa for 3 years. Patients are followed every 3 months for the first year, then every 6 months for the next 2 years. PROJECTED ACCRUAL: There will be 40-45 patients accrued into this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed previously untreated acute myelogenous leukemia (AML); FAB M1, M2, M4, M5, M6, or M7 - No AML secondary to chemotherapy, radiation therapy, or toxic agents - No history of myelodysplastic syndromes - If possible, patient should be enrolled on protocol RUSH-CYL-9003 --Prior/Concurrent Therapy-- - Biologic therapy: At least 2 weeks since prior interferon; At least 2 weeks since prior hematopoietic growth factors (including erythropoietin) - Chemotherapy: At least 2 weeks since prior chemotherapy - Endocrine therapy: At least 2 weeks since prior steroids - Radiotherapy: Not specified - Surgery: Not specified - Other: At least 2 weeks since prior retinoids --Patient Characteristics-- - Age: 70 and under - Performance status: 0-3 - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin greater than 2.0 mg/dL and no greater than 3.0 mg/dL allowed with 50% reduction in drug doses - Renal: Creatinine less than 3.0 mg/dL - Cardiovascular: No overt congestive heart failure; No uncontrollable ventricular arrhythmias; No uncontrollable hypertension; If cardiac ejection fraction is less than 45% of predicted, an echocardiogram and a cardiac consult must be obtained to ascertain cardiac tolerance of anthracycline therapy - Neurological: No cerebellar dysfunction - Other: Fever, infection, or other complications of disease allowed; Not pregnant or nursing; Effective contraception required of all fertile patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HarveyPreisler, Study Chair, Rush Cancer Institute at Rush University Medical Center
Angelo P. Creticos, M.D. Cancer Center
Chicago, Illinois, 60657
United States
Rush-Riverside Cancer Center
Kankakee, Illinois, 60901
United States
Rush Cancer Institute
Chicago, Illinois, 60612
United States
Cook County Hospital
Chicago, Illinois, 60612-9985
United States
Additional Information:
Study ID Numbers: CDR0000066413; RUSH-AML-9754,NCI-V98-1445,ALZA-RUSH-AML-9754
Study Start Date: April 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003405
Other Adult Acute Myeloblastic Leukemia Without Maturation (m1) Studies:
1. Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia
2. Combination Chemotherapy Followed by Melphalan and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Acute Myeloid Leukemia
Related Studies:
Other adult acute myeloblastic leukemia without maturation (M1) Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia
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