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

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00066794

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 II

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:

MedlinePlus related topics: Acute Myeloid Leukemia Cancer Leukemia

Drug Information available for: Cytarabine hydrochloride Daunorubicin Daunorubicin hydrochloride Cyclosporine Cyclosporin Granulocyte-macrophage colony-stimulating factor Filgrastim Sargramostim Lenograstim Granulocyte colony-stimulating factor Cytarabine

U.S. FDA Resources

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:

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

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

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

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

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

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

Show 97 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Thomas R. Chauncey, MD, PhD	Department of Veterans Affairs
Principal Investigator:	Cheryl L. Willman, MD	University of New Mexico
Principal Investigator:	Marilyn L. Slovak, PhD	Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cyclosporins
Cyclosporine
Cytarabine
Lenograstim
Daunorubicin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents

Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Antibiotics, Antineoplastic
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on February 12, 2012