S0301 Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00066794
First received: August 6, 2003
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as cyclosporine, daunorubicin, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving cyclosporine together with daunorubicin and cytarabine works in treating older patients with untreated acute myeloid leukemia.


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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Complete remission (CR) [ Time Frame: After induction therapy is completed ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: July 2004
Study Completion Date: January 2010
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: filgrastim
    5 mcg/kg/d IV or SC starting apx day 15
    Biological: sargramostim
    250 mcg/kg/d IV or SC starting apx day 15
    Drug: cyclosporine
    ind: 6 mg/kg load IV over 2 hrs days 0-2 followed by 16 mg/dg/d continuous IV days 2-74 consol: 6 mg/kg load IV over 2 hrs days 0-2 followed by 16 mg/dg/d continuous IV days 2-50
    Drug: cytarabine
    ind: 200 mg/m2/d cont IV days 2-74
    Drug: daunorubicin hydrochloride
    ind: 45 mg/m2/d cont IV days 2-74
Detailed Description:

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.

  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)

    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066794

  Show 97 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Thomas R. Chauncey, MD, PhD Department of Veterans Affairs
Principal Investigator: Cheryl L. Willman, MD University of New Mexico Cancer Center
Principal Investigator: Marilyn L. Slovak, PhD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00066794     History of Changes
Other Study ID Numbers: CDR0000318831, S0301, U10CA032102
Study First Received: August 6, 2003
Last Updated: January 12, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
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)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Cyclosporine
Cyclosporins
Cytarabine
Daunorubicin
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Antiviral Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014