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S0301 Cyclosporine, Daunorubi...

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

Last Updated: 2015-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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filgrastim

5 mcg/kg/d IV or SC starting apx day 15

Intervention Type BIOLOGICAL

sargramostim

250 mcg/kg/d IV or SC starting apx day 15

Intervention Type BIOLOGICAL

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

Intervention Type DRUG

cytarabine

ind: 200 mg/m2/d cont IV days 2-74

Intervention Type DRUG

daunorubicin hydrochloride

ind: 45 mg/m2/d cont IV days 2-74

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

56 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas R. Chauncey, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System

Cheryl L. Willman, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico Cancer Center

Marilyn L. Slovak, PhD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Comprehensive Cancer Center

Locations

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Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Site Status

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, United States

Site Status

Mercy Regional Cancer Center at Mercy Medical Center

Redding, California, United States

Site Status

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, United States

Site Status

Saint Anthony's Hospital at Saint Anthony's Health Center

Alton, Illinois, United States

Site Status

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Site Status

Southwest Medical Center

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Site Status

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, United States

Site Status

Stormont-Vail Cancer Center

Topeka, Kansas, United States

Site Status

St. Francis Comprehensive Cancer Center

Topeka, Kansas, United States

Site Status