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

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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	Drug: cyclosporine Drug: cytarabine Drug: daunorubicin hydrochloride Drug: filgrastim Drug: sargramostim	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease status [ Designated as safety issue: No ]
Complete remission (CR) [ Designated as safety issue: No ]
Treatment failure [ Designated as safety issue: No ]
Relapse from CR [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Performance status [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	July 2004

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

Investigator:	Thomas R. Chauncey, MD, PhD	Veterans Affairs Medical Center - Seattle
Investigator:	Cheryl L. Willman, MD	University of New Mexico
Investigator:	Marilyn L. Slovak, PhD	Beckman Research Institute

More Information

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

Study ID Numbers:	CDR0000318831, SWOG-S0301
Study First Received:	August 6, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00066794
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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)

Study placed in the following topic categories:

Leukemia, Monocytic, Acute
Daunorubicin
Cyclosporine
Clotrimazole
Miconazole
Tioconazole
Acute myelogenous leukemia
Acute myelomonocytic leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Di Guglielmo's syndrome

Cyclosporins
Leukemia, Myelomonocytic, Acute
Leukemia
Leukemia, Erythroblastic, Acute
Acute erythroblastic leukemia
Acute myeloid leukemia, adult
Congenital Abnormalities
Acute myelocytic leukemia
Acute monoblastic leukemia
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Antibiotics, Antineoplastic
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 14, 2009