Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 56 and over NCI SWOG-S0301 S0301, NCT00066794

Objectives

1. Determine the safety and efficacy of cyclosporine, daunorubicin, and cytarabine in older patients with previously untreated acute myeloid leukemia.
2. Determine the frequency and severity of toxic effects of this regimen in these patients.
3. Determine, preliminarily, the frequency and prognostic significance of functional and phenotypic P-glycoprotein expression and cytogenetics in patients treated with this regimen.
4. Determine, preliminarily, the pharmacokinetic characteristics of this regimen in these patients.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent pegfilgrastim

Chemotherapy

• At least 30 days since prior low-dose cytarabine (less than 100 mg/m²/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

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

Expected Enrollment

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

Outcomes

Disease status
Complete remission (CR)
Treatment failure
Relapse from CR
Toxicity
Performance status
Survival

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Thomas R. Chauncey, MD, PhD, Study coordinator		Ph: 206-764-2709; 800-329-8387
Cheryl Willman, MD, Study coordinator		Ph: 505-272-5622 Email: cwillman@salud.unm.edu
Marilyn Slovak, PhD, Study coordinator		Ph: 626-256-4673 ext. 62438; 800-826-4673

Registry Information
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
Trial Start Date		2004-07-26
Registered in ClinicalTrials.gov		NCT00066794
Date Submitted to PDQ		2003-07-02
Information Last Verified		2006-12-15
NCI Grant/Contract Number		CA32102

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