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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia  Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
For Condition: adult acute minimally differentiated myeloid leukemia (M0),adult acute megakaryocytic leukemia (M7),adult acute myeloblastic leukemia without maturation (M1),secondary acute myeloid leukemia,adult acute poorly differentiated monocytic leukemia (M5a),adult acute erythroleukemia (M6),adult acute myeloblastic leukemia with maturation (M2),adult acute differentiated monocytic leukemia (M5b),adult acute myelomonocytic leukemia (M4),recurrent adult acute myeloid leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Protein Design Labs
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if chemotherapy is more effective with or without monoclonal antibody therapy for acute myelogenous leukemia. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have refractory or relapsed acute myelogenous leukemia.
Details: OBJECTIVES: I. Compare the efficacy, safety, pharmacokinetics, and immunogenicity of mitoxantrone, etoposide, and cytarabine (MEC) with or without monoclonal antibody HuG1-M195 in patients with refractory or relapsed acute myelogenous leukemia. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by age (under 50 vs 50 and over) and duration of previous complete remission (CR) (0-6 vs 7-12 months). All patients receive induction chemotherapy comprised of cytarabine IV over 2 hours, mitoxantrone IV over a maximum of 20 minutes, and etoposide IV over 1-2 hours on days 1-6. On day 5 of induction, patients are randomized to one of two treatment arms: Arm I: Patients receive day 6 of induction chemotherapy. Patients then receive monoclonal antibody HuG1-M195 (MOAB HuM195) IV over 4 hours on days 6-9 or 7-10. Treatment with MOAB HuM195 repeats every 2 weeks for 2 courses (courses 1 and 2) in the absence of disease progression or unacceptable toxicity. During course 1, MOAB HuM195 begins 30 minutes to 24 hours postchemotherapy. Patients who do not achieve CR by day 70 of induction and show evidence of bone marrow progression (regimen failure (RF)) are taken off study. Patients without RF are assigned to one of two consolidation groups based on response: Group A (CR): Patients receive consolidation chemotherapy comprised of mitoxantrone IV over a maximum of 20 minutes on days 1 and 2, and cytarabine IV over 2 hours and etoposide IV over 1-2 hours on days 1-4. Patients with New York Heart Association class II heart disease preconsolidation receive no mitoxantrone during consolidation. Patients receive MOAB HuM195 IV over 4 hours on days 4-7 or 5-8. Treatment with MOAB HuM195 repeats every 2 weeks for 2 additional courses (courses 3 and 4). During course 3, MOAB HuM195 begins 30 minutes to 24 hours postchemotherapy. Group B (partial remission (PR), hematologic improvement (HI), or stable disease (SD)): Patients receive MOAB HuM195 as in group A but no consolidation chemotherapy. Patients without RF after treatment on group A or B receive maintenance MOAB HuM195 IV over 4 hours on days 1-4. Treatment repeats every month for 8 additional courses (courses 5-12). Arm II: Patients receive day 6 of induction chemotherapy. Patients receive no MOAB HuM195 during the entire study. Patients without RF at day 70 of induction are assigned to one of two consolidation groups based on response: Group C (CR): Patients receive consolidation chemotherapy as in group A. Group D (PR, HI, or SD): Patients receive no further treatment. Patients may be eligible to receive MOAB HuM195 on PDL Study 195-302. Patients are followed every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A maximum of 200 patients (100 per arm) 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 acute myelogenous leukemia (AML) that may have been primary AML, secondary AML, or preceded by hematologic disorder; All FAB subtypes except M3 - Must meet one of the following three criteria: First relapse within 1 year after documentation of a previous complete remission (CR) achieved by chemotherapy; Refractory to prior chemotherapy comprised of a minimum of 1 induction course, including cytarabine at a minimum of 500 mg/m2 (e.g., 100 mg/m2/day for 5 days) plus an anthracycline; No high dose cytarabine (no cumulative dose greater than 3 g/m2); First relapse from a previous CR with subsequent autologous bone marrow transplantation (BMT), only if all of the following criteria are met: First BMT At least 100 days but less than 1 year posttransplantation; At least 25% cellularity of the bone marrow; Previous BMT included full hematopoietic recovery, defined by all of the following: Hemoglobin at least 10 g/dL (without transfusion); Platelet count at least 100,000/mm3 (without transfusion); Absolute neutrophil count at least 1,500/mm3 - No transplantation candidates - Bone marrow blasts (leukemic cells) greater than 10% - No chronic myelogenous leukemia in blast crisis - No active CNS leukemia --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; At least 30 days since prior experimental biologic therapy (e.g., interleukin-2); No concurrent biologic therapy, including bone marrow transplantation - Chemotherapy: See Disease Characteristics; For first relapse AML with recent or prior chemotherapy: Prior hydroxyurea given as a short course (up to 48 hours) allowed, if needed, to reduce the peripheral leukocyte count; Hydroxyurea must be discontinued prior to study; For refractory AML with recent or prior chemotherapy: Greater than 2 weeks since prior chemotherapy except hydroxyurea given as above; No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No concurrent radiotherapy - Surgery: Not specified - Other: No other concurrent experimental therapy; Concurrent therapy for other preexisting diseases allowed --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 50-100% - Life expectancy: Not specified - Hematopoietic: See Disease Characteristics - Hepatic: Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration); SGOT or SGPT no greater than 4 times upper limit of normal (unless related to AML) - Renal: Creatinine less than 2.0 mg/dL (unless related to AML) - Cardiovascular: Left ventricular function normal; No unstable cardiac arrhythmias, unstable angina pectoris, or myocardial infarction within the past 6 months; No New York Heart Association class III or IV heart disease; No electrocardiogram evidence of active ischemia - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 1 month after study; HIV negative; No other active malignancy requiring therapy; No active serious infection that is uncontrolled by antimicrobial therapy; Medically stable; No significant organ dysfunction
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DanielLevitt, Study Chair, Protein Design Labs
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
Louisiana State University School of Medicine
Shreveport, Louisiana, 71130-3932
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Universitaetsklinikum Benjamin Franklin
Berlin, , D-12200
Germany
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
CHRU de Nancy - Hopitaux de Brabois
Vandoeuvre-les-Nancy, , 54511
France
Akron General Medical Center
Akron, Ohio, 44302
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Nevada Cancer Center
Las Vegas, Nevada, 89106
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2516
United States
North Mississippi Hematology and Oncology Associates, Ltd.
Tupelo, Mississippi, 38801
United States
Centre Hospitalier Regional et Universitaire d'Angers
Angers, , 49033
France
Emory Clinic
Atlanta, Georgia, 30322
United States
Klinikum der J.W. Goethe Universitaet
Frankfurt, , D-60590
Germany
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
United Kingdom
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
North Shore University Hospital
Manhasset, New York, 11030
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Westfaelische Wilhelms-Universitaet
Munster, , DOH-4-8149
Germany
Queen Elizabeth II Health Science Center
Halifax, Nova Scotia, B3H 2Y9
Canada
Sidney Kimmel Cancer Center
San Diego, California, 92121
United States
University of Rostock
Rostock, , 18057
Germany
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Royal Free Hospital
Hampstead, London, England, NW3 2QG
United Kingdom
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Leeds Teaching Hospital Trust
Leeds, England, LS1 3EX
United Kingdom
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Munich, , D-81675
Germany
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Sutter Cancer Center
Sacramento, California, 95816
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
West Clinic, P.C.
Memphis, Tennessee, 38117
United States
New York Medical College
Valhalla, New York, 10595
United States
Academisch Medisch Centrum
Amsterdam, , 1105 AZ
Netherlands
Algemeen Ziekenhuis Middelheim
Antwerp, , 2020
Belgium
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
St. Joseph Hospital - Orange
Orange, California, 92613-5600
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Washington University Barnard Cancer Center
St. Louis, Missouri, 63110
United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
United States
Institut Jules Bordet
Brussels, , 1000
Belgium
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Additional Information:
Study ID Numbers: CDR0000068061; MSKCC-00029,UCLA-9910050,NCI-G00-1819,PDL-195-301
Study Start Date: March 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006045
Other Adult Acute Minimally Differentiated Myeloid Leukemia (m0) Studies:
1. Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia
2. High Dose Chemotherapy, Peripheral Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
3. Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia
4. Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia
5. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
Related Studies:
Other adult acute minimally differentiated myeloid leukemia (M0) Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
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