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

NCT00066794 | Completed Phase 2

• 2 other identifiers: S0301U10CA032102
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 97

Brief Summary

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.

Conditions

Leukemia

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• Complete remission (CR)

  After induction therapy is completed

Interventions

filgrastim BIOLOGICAL

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

sargramostim BIOLOGICAL

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

cyclosporine DRUG

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

cytarabine DRUG

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

daunorubicin hydrochloride DRUG

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

Eligibility Criteria

• Age: 56 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (97)

Mobile Infirmary Medical Center

Mobile, Alabama, 36652-2144, United States

Location

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5024, United States

Location

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

Orange, California, 92868, United States

Location

Mercy Regional Cancer Center at Mercy Medical Center

Redding, California, 96049, United States

Location

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, 83712, United States

Location

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

Alton, Illinois, 62002, United States

Location

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Stormont-Vail Cancer Center

Topeka, Kansas, 66604, United States

Location

St. Francis Comprehensive Cancer Center

Topeka, Kansas, 66606, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Tulane Cancer Center

Alexandria, Louisiana, 71315-3198, United States

Location

Louisiana State University Health Sciences Center - Monroe

Monroe, Louisiana, 71210, United States

Location

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, 71130-3932, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

Bay Regional Medical Center

Bay City, Michigan, 48708, United States

Location

Mecosta County Medical Center

Big Rapids, Michigan, 49307, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health Hospital - Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Metropolitan Hospital

Grand Rapids, Michigan, 49506, United States

Location

Holland Community Hospital

Holland, Michigan, 49423, United States

Location

Hackley Hospital

Muskegon, Michigan, 49443, United States

Location

Providence Cancer Institute at Providence Hospital - Southfield Campus

Southfield, Michigan, 48075, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63701, United States

Location

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

Gape Girardeau, Missouri, 63701, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare

Billings, Montana, 59101, United States

Location

Deaconess Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

St. James Community Hospital

Butte, Montana, 59701, United States

Location

Big Sky Oncology

Great Falls, Montana, 59405, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Sletten Regional Cancer Institute at Benefis Healthcare

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Clinic of Dr. Judy L. Schmidt

Missoula, Montana, 59804, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Highland Hospital of Rochester

Rochester, New York, 14620, United States

Location

Interlakes Oncology/Hematology PC

Rochester, New York, 14623, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893-3428, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

Grant Riverside Cancer Services

Columbus, Ohio, 43215, United States

Location

Mount Carmel Health - West Hospital

Columbus, Ohio, 43222, United States

Location

Doctors Hospital at Ohio Health

Columbus, Ohio, 43228, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

Mercy Medical Center

Springfield, Ohio, 45504, United States

Location

Community Hospital of Springfield and Clark County

Springfield, Ohio, 45505, United States

Location

Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

Westerville, Ohio, 43081, United States

Location

Tod Children's Hospital - Forum Health

Youngstown, Ohio, 44501, United States

Location

Genesis - Good Samaritan Hospital

Zanesville, Ohio, 43701, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Monocytic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute; Congenital Abnormalities; Leukemia, Erythroblastic, Acute

Interventions

Filgrastim; sargramostim; Cyclosporine; Cytarabine; Daunorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Aminoglycosides; Glycosides

Study Officials

• Thomas R. Chauncey, MD, PhD

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

• Cheryl L. Willman, MD

  University of New Mexico Cancer Center

  PRINCIPAL INVESTIGATOR

• Marilyn L. Slovak, PhD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: July 1, 2004
• Primary Completion: February 1, 2007
• Study Completion: January 1, 2010
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

US (97)