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A Phase II Study Of Induction With Daunorubicin, Cytarabine, And Cyclosporine All By Continuous IV Infusion 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 Induction With Daunorubicin, Cytarabine, And Cyclosporine All By Continuous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older


OBJECTIVES:

- Determine the safety and efficacy of cyclosporine, daunorubicin, and cytarabine in
older patients with previously untreated acute myeloid leukemia.

- Determine the frequency and severity of toxic effects of this regimen in these
patients.

- Determine, preliminarily, the frequency and prognostic significance of functional and
phenotypic P-glycoprotein expression and cytogenetics in patients treated with this
regimen.

- Determine, preliminarily, the pharmacokinetic characteristics of this regimen in these
patients.

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive cyclosporine IV and daunorubicin IV continuously on
days 1-3 and cytarabine IV continuously on days 1-7. Patients who achieve complete
response (CR) after chemotherapy receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV
or subcutaneously beginning on day 15 or 20 and continuing until blood counts recover.
Patients who maintain CR after 2 courses of induction therapy proceed to consolidation
therapy.

- Consolidation therapy: Patients receive treatment as in induction therapy with
cyclosporine and daunorubicin on days 1-2 and cytarabine on days 1-5. Patients
achieving CR receive an additional course of chemotherapy beginning at least 14 days
after completion of the first course of cytarabine.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then
annually for 3 years.

PROJECTED ACCRUAL: A total of 25-64 patients will be accrued for this study within 13
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Morphologically confirmed acute myeloid leukemia (AML)

- Differential diagnosis of AML based on FAB classification system

- M0-M7 (No M3)

- No blastic transformation of chronic myelogenous leukemia

- Must be currently registered on protocols SWOG-9007 and SWOG-S9910

PATIENT CHARACTERISTICS:

Age

- 56 and over

Performance status

- Zubrod 0-3 (for patients 56 to 60 years of age) OR

- Zubrod 0-2 (for patients 61 to 70 years of age) OR

- Zubrod 0-1 (for patients 71 years of age and over)

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Bilirubin no greater than 2 times upper limit of normal (ULN) unless elevated
unconjugated hyperbilirubinemia is secondary to Gilbert's syndrome or hemolysis and
not to liver dysfunction

- AST and/or ALT no greater than 4 times ULN

Renal

- Creatinine no greater than 1.5 times ULN AND/OR

- Creatinine clearance greater than 40 mL/min

Cardiovascular

- Left ventricular function normal

- Ejection fraction at least 50% by MUGA or echocardiogram

- No unstable cardiac arrhythmias

- No unstable 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, or adequately treated
stage I or II cancer that is currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent pegfilgrastim

Chemotherapy

- At least 30 days since prior low-dose cytarabine (less than 100 mg/m^2/day) for
myelodysplastic syndromes and recovered

- Prior hydroxyurea to control high cell counts allowed

- No prior systemic chemotherapy for acute leukemia

- Concurrent single-dose 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:

Complete remission (CR)

Outcome Time Frame:

After induction therapy is completed

Safety Issue:

No

Principal Investigator

Thomas R. Chauncey, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Veterans Affairs

Authority:

United States: Federal Government

Study ID:

CDR0000318831

NCT ID:

NCT00066794

Start Date:

July 2004

Completion Date:

January 2010

Related Keywords:

  • Leukemia
  • adult acute monocytic leukemia (M5b)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute minimally differentiated myeloid leukemia (M0)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • untreated adult acute myeloid leukemia
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult pure erythroid leukemia (M6b)
  • adult erythroleukemia (M6a)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Scott and White HospitalTemple, Texas  76508
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Wesley Medical CenterWichita, Kansas  67214
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Great Falls ClinicGreat Falls, Montana  59405
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
St. Luke's Mountain States Tumor Institute - BoiseBoise, Idaho  83712-6297
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Tod Children's Hospital - Forum HealthYoungstown, Ohio  44501
Interlakes Oncology/Hematology PCRochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Southwest Medical CenterLiberal, Kansas  67901
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Metropolitan HospitalGrand Rapids, Michigan  49506
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grant Riverside Cancer ServicesColumbus, Ohio  43215
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Mount Carmel Cancer Services at Mount Carmel St. Ann's HospitalWesterville, Ohio  43081
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Stormont-Vail Cancer CenterTopeka, Kansas  66604
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Louisiana State University Health Sciences Center - MonroeMonroe, Louisiana  71210
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Bay Regional Medical CenterBay City, Michigan  48708
Mecosta County Medical CenterBig Rapids, Michigan  49307
Providence Cancer Institute at Providence Hospital - Southfield CampusSouthfield, Michigan  48075
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Highland Hospital of RochesterRochester, New York  14620
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Mercy Medical CenterSpringfield, Ohio  45504
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Tulane Cancer CenterNew Orleans, Louisiana  70112
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Rutherford HospitalRutherfordton, North Carolina  28139
AnMed Health Cancer CenterAnderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Sletten Regional Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Clinic of Dr. Judy L. SchmidtMissoula, Montana  59804
Mercy Regional Cancer Center at Mercy Medical CenterRedding, California  96049