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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


Phase 2
56 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response

Outcome Time Frame:

after induction therapy is completed

Safety Issue:

Yes

Principal Investigator

Thomas R. Chauncey, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Veterans Affairs

Authority:

United States: Federal Government

Study ID:

CDR0000067450

NCT ID:

NCT00004217

Start Date:

February 2000

Completion Date:

March 2006

Related Keywords:

  • Leukemia
  • untreated adult acute myeloid leukemia
  • adult acute erythroid leukemia (M6)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute monocytic leukemia (M5b)
  • adult acute minimally differentiated myeloid leukemia (M0)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Arizona Cancer Center Tucson, Arizona  85724
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of California Davis Medical Center Sacramento, California  95817
CCOP - Wichita Wichita, Kansas  67214-3882
MBCCOP - LSU Medical Center New Orleans, Louisiana  70112
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
Loyola University Medical Center Maywood, Illinois  60153
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
MBCCOP - University of South Alabama Mobile, Alabama  36688
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
Beckman Research Institute, City of Hope Los Angeles, California  91010
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
CCOP - Southwestern Vermont Regional Cancer Center Bennington, Vermont  05201
Swedish Cancer Institute Seattle, Washington  98104
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - Scott and White Hospital Temple, Texas  76508
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines, Illinois  60141
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Boston Medical Center Boston, Massachusetts  02118
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Veterans Affairs Medical Center - Biloxi Biloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Oklahoma Medical Research Foundation Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Texas Tech University Health Science Center Lubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences University Portland, Oregon  97201-3098
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
Veterans Affairs Medical Center - Dallas Dallas, Texas  75216
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209