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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 CenterTucson, Arizona  85724
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of California Davis Medical CenterSacramento, California  95817
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
MBCCOP - University of South AlabamaMobile, Alabama  36688
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Beckman Research Institute, City of HopeLos Angeles, California  91010
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Southwestern Vermont Regional Cancer CenterBennington, Vermont  05201
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Texas Tech University Health Science CenterLubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209