S9918 PSC 833, Daunorubicin, and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00004217
First received: January 28, 2000
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Leukemia
Biological: filgrastim
Biological: sargramostim
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: valspodar
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • response [ Time Frame: after induction therapy is completed ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: February 2000
Study Completion Date: March 2006
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: filgrastim
    5 μg/kg/day IV or SC
    Biological: sargramostim
    5 μg/kg/day IV or SC starting d 15
    Drug: cytarabine
    Ara-C continuous IV: Hours 2.5 - 170.5 before PSC-833
    Drug: daunorubicin hydrochloride
    continuous IV: Hours 2 - 74 before PSC-833
    Drug: valspodar
    2 mg/kg load IV over 2 hrs (loading); 10 mg/kg/day Continuous hours 0 - 96
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.

  Eligibility

Ages Eligible for Study:   56 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004217

  Hide Study Locations
Locations
United States, Alabama
MBCCOP - University of South Alabama
Mobile, Alabama, United States, 36688
United States, Arizona
CCOP - Greater Phoenix
Phoenix, Arizona, United States, 85006-2726
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, United States, 85012
Arizona Cancer Center
Tucson, Arizona, United States, 85724
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States, 72205
United States, California
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
Beckman Research Institute, City of Hope
Los Angeles, California, United States, 91010
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
University of California Davis Medical Center
Sacramento, California, United States, 95817
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94115-0128
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States, 60141
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40511-1093
United States, Louisiana
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71130
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States, 48105
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Providence Hospital - Southfield
Southfield, Michigan, United States, 48075-9975
United States, Mississippi
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States, 39531-2410
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States, 39216
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States, 64128
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States, 87108-5138
United States, New York
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States, 11209
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
United States, Ohio
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45219
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220-2288
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44195
CCOP - Columbus
Columbus, Ohio, United States, 43206
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
CCOP - Dayton
Kettering, Ohio, United States, 45429
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, United States, 97201-3098
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97207
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States, 75216
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
University of Texas Medical Branch
Galveston, Texas, United States, 77555-1329
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Texas Tech University Health Science Center
Lubbock, Texas, United States, 79423
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78284
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Veterans Affairs Medical Center - Temple
Temple, Texas, United States, 76504
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84132
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Vermont
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, United States, 05201
United States, Washington
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Swedish Cancer Institute
Seattle, Washington, United States, 98104
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Thomas R. Chauncey, MD, PhD Department of Veterans Affairs
  More Information

Additional Information:
No publications provided by Southwest Oncology Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00004217     History of Changes
Other Study ID Numbers: CDR0000067450, S9918, U10CA032102
Study First Received: January 28, 2000
Last Updated: January 12, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
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)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Daunorubicin
Lenograstim
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 16, 2014