- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004217
S9918 PSC 833, Daunorubicin, and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase II Study of Daunomycin and ARA-C Given by Continuous IV Infusion With PSC-833 for Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) in Patients of Age 56 or Older
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PSC 833 may help chemotherapy drugs kill more cancer cells by making them more sensitive to the drugs.
PURPOSE: Phase II trial to study the effectiveness of PSC 833, daunorubicin, and cytarabine in treating older patients who have newly diagnosed acute myeloid leukemia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Determine the safety and efficacy of daunorubicin and cytarabine by continuous infusion and PSC 833 in patients over age 56 with newly diagnosed acute myeloid leukemia. II. Determine the frequency and severity of toxicities of this regimen in these patients. III. Determine the frequency and prognosis of functional and phenotypic P-glycoprotein expression, cytogenetics, and pharmacokinetics in this population.
OUTLINE: This is a multicenter study. Patients receive induction chemotherapy consisting of PSC 833 IV over 2 hours on day 1, then continuously for 96 hours; daunorubicin IV continuously on days 1-3; and cytarabine IV continuously on days 1-7. Filgrastim (G-CSF) or sargramostim (GM-CSF) is administered subcutaneously (SQ) or IV beginning on day 15 and continuing until blood counts recover or day 21. If patients do not achieve complete remission after one course, a second course is administered. Patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status after 1 or 2 courses of induction chemotherapy proceed to consolidation therapy, which begins upon recovery from induction therapy. Consolidation therapy consists of PSC 833 over 2 hours on day 1, daunorubicin IV over 1-5 minutes on days 1 and 2, and cytarabine IV continuously on days 1-5. Treatment repeats for a total of 2 courses. Patients are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study within 8-9 months.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- BC Cancer Agency
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Alabama
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Mobile, Alabama, United States, 36688
- MBCCOP - University of South Alabama
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Arizona
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Phoenix, Arizona, United States, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, United States, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center
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Tucson, Arizona, United States, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, United States, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Long Beach, California, United States, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, United States, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, United States, 91010
- Beckman Research Institute, City of Hope
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Martinez, California, United States, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, United States, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, United States, 95817
- University of California Davis Medical Center
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San Francisco, California, United States, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, United States, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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Santa Rosa, California, United States, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, United States, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, United States, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, United States, 80262
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, United States, 30342-1701
- CCOP - Atlanta Regional
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Cancer Research Center of Hawaii
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Illinois
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Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
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Hines, Illinois, United States, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, United States, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, United States, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, United States, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, United States, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, United States, 70112
- Veterans Affairs Medical Center - New Orleans
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Shreveport, Louisiana, United States, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, United States, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, United States, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, United States, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, United States, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Detroit, Michigan, United States, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, United States, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield, Michigan, United States, 48075-9975
- Providence Hospital - Southfield
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Mississippi
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Biloxi, Mississippi, United States, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, United States, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, United States, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, United States, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, United States, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, United States, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, United States, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, United States, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, United States, 87131
- MBCCOP - University of New Mexico HSC
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New York
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Brooklyn, New York, United States, 11209
- Veterans Affairs Medical Center - Brooklyn
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New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, United States, 45219
- Barrett Cancer Center, The University Hospital
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Cincinnati, Ohio, United States, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Cancer Center
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Columbus, Ohio, United States, 43206
- CCOP - Columbus
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Dayton, Ohio, United States, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, United States, 45429
- CCOP - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, United States, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, United States, 97201-3098
- Oregon Cancer Center at Oregon Health Sciences University
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Portland, Oregon, United States, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, United States, 97213
- CCOP - Columbia River Program
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South Carolina
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Greenville, South Carolina, United States, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
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Texas
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Dallas, Texas, United States, 75216
- Veterans Affairs Medical Center - Dallas
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Dallas, Texas, United States, 75235-9154
- Simmons Cancer Center - Dallas
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Fort Sam Houston, Texas, United States, 78234
- Brooke Army Medical Center
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Galveston, Texas, United States, 77555-1329
- University of Texas Medical Branch
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Houston, Texas, United States, 77030
- University of Texas - MD Anderson Cancer Center
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Lubbock, Texas, United States, 79423
- Texas Tech University Health Science Center
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San Antonio, Texas, United States, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, United States, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, United States, 84132
- Huntsman Cancer Institute
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Salt Lake City, Utah, United States, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Vermont
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Bennington, Vermont, United States, 05201
- CCOP - Southwestern Vermont Regional Cancer Center
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Washington
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Seattle, Washington, United States, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, United States, 98104
- Swedish Cancer Institute
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Seattle, Washington, United States, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, United States, 98405-0986
- CCOP - Northwest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Morphologically confirmed acute myeloid leukemia (AML) No M3 AML or blastic phase chronic myelogenous leukemia Must be registered on protocols SWOG-9007 and SWOG-9910
PATIENT CHARACTERISTICS: Age: 56 and over Performance status: Zubrod 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT/SGPT no greater than 4 times ULN Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance greater than 40 mL/min Cardiovascular: LVEF at least 50% by MUGA or echocardiogram No unstable cardiac arrhythmias or angina Other: Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for acute leukemia Prior hydroxyurea to control high cell counts allowed At least 30 days since prior low dose cytarabine (less than 100 mg/m2/day) for myelodysplastic syndrome and recovered Single dose of prior or concurrent (with induction chemotherapy) intrathecal chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
response
Time Frame: after induction therapy is completed
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after induction therapy is completed
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Thomas R. Chauncey, MD, PhD, VA Puget Sound Health Care System
Publications and helpful links
General Publications
- Medeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19.
- Medeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- untreated adult acute myeloid leukemia
- adult acute erythroid leukemia (M6)
- adult acute megakaryoblastic leukemia (M7)
- adult acute minimally differentiated myeloid leukemia (M0)
- adult acute monoblastic leukemia (M5a)
- adult acute monocytic leukemia (M5b)
- adult acute myeloblastic leukemia with maturation (M2)
- adult acute myeloblastic leukemia without maturation (M1)
- adult acute myelomonocytic leukemia (M4)
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cytarabine
- Daunorubicin
- Sargramostim
Other Study ID Numbers
- S9918 (Other Identifier: SWOG)
- U10CA032102 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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