S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia

NCT00053014 | Terminated Phase 2 Results DMC

• 2 other identifiers: S0125U10CA032102
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 83

Brief Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine and mycophenolate mofetil may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of chemotherapy and total-body irradiation followed by donor peripheral stem cell transplantation, cyclosporine, and mycophenolate mofetil in treating older patients who have acute myeloid leukemia.

Conditions

Leukemia

Keywords

adult acute myeloid leukemia in remission; 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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  measured from date of registration to study until death from any cause with patients still alive censored at date of last contact

  1 year

Secondary Outcomes (1)

• Serious Adverse Events

  9 months

Study Arms (1)

treatment

EXPERIMENTAL

patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - cyclosporine 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); mycophenolate mofetil 15mg/kg bid PO D0 to +27

Biological: therapeutic allogeneic lymphocytes; Drug: cyclosporine; Drug: fludarabine; Drug: mycophenolate mofetil; Procedure: peripheral blood stem cell transplantation; Radiation: radiation therapy

Interventions

therapeutic allogeneic lymphocytes BIOLOGICAL

treatment

cyclosporine DRUG

treatment

fludarabine DRUG

treatment

mycophenolate mofetil DRUG

Also known as: MMF

treatment

peripheral blood stem cell transplantation PROCEDURE

treatment

radiation therapy RADIATION

treatment

Eligibility Criteria

• Age: 55 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Morphologically confirmed acute myeloid leukemia (AML) (within 180 days of diagnosis) OR * Secondary AML (secondary to myelodysplastic syndromes (MDS) or to prior leukemogenic therapy) * Must have A1 marrow, B1 blood, and C1 extramedullary disease status * Must have received prior remission induction chemotherapy * Must have a genotypically HLA-identical sibling donor available that is not a monozygotic identical twin * No M3 AML or blastic transformation of chronic myelogenous leukemia * If history of CNS leukemia, no leukemia cells in CNS by lumbar puncture within past 7 days * Must be concurrently enrolled on protocols SWOG-9007 and SWOG-S9910 PATIENT CHARACTERISTICS: Age * 55 to 69 Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No other malignancy within the past 2 years except for the following: * Adequately treated basal cell or squamous cell skin cancer * Carcinoma in situ of the cervix * Adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy * No prior allogeneic hematopoietic stem cell transplantation Chemotherapy * See Disease Characteristics * Prior consolidation therapy allowed Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Prior organ transplantation allowed provided not concurrently receiving immunosuppressive therapy

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 (83)

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, 85723, United States

Location

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Veterans Affairs Medical Center - Little Rock

Little Rock, Arkansas, 72205, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Scripps Cancer Center at Scripps Clinic

La Jolla, California, 92037-1027, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1678, United States

Location

Veterans Affairs Outpatient Clinic - Martinez

Martinez, California, 94553, United States

Location

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

Orange, California, 92868, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

General Robert Huyser Cancer Center at David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

John Muir/Mt. Diablo Comprehensive Cancer Center

Walnut Creek, California, 94598, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

Veterans Affairs Medical Center - Tampa (Haley)

Tampa, Florida, 33612, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, 30033, United States

Location

Dwight David Eisenhower Army Medical Center

Fort Gordon, Georgia, 30905-5650, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Mountain States Tumor Institute - Boise

Boise, Idaho, 83712, United States

Location

Veterans Affairs Medical Center - Chicago Westside Hospital

Chicago, Illinois, 60612, United States

Location

Veterans Affairs Medical Center - Hines

Hines, Illinois, 60141, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153-5500, United States

Location

Indiana Blood and Marrow Transplantation

Beech Grove, Indiana, 46107, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7353, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Veterans Affairs Medical Center - Wichita

Wichita, Kansas, 67218, United States

Location

Veterans Affairs Medical Center - Lexington

Lexington, Kentucky, 40502-2236, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0084, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tulane Cancer Center at Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112, United States

Location

Veterans Affairs Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

New Orleans Cancer Institute at Memorial Medical Center

New Orleans, Louisiana, 70115, United States

Location

Veterans Affairs Medical Center - Shreveport

Shreveport, Louisiana, 71101-4295, United States

Location

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, 71130-3932, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0948, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, 48201-1932, United States

Location

Josephine Ford Cancer Center at Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Providence Cancer Institute at Providence Hospital - Southfield Campus

Southfield, Michigan, 48075, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Veterans Affairs Medical Center - Jackson

Jackson, Mississippi, 39216, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Saint Louis University Cancer Center

St Louis, Missouri, 63110, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Veterans Affairs Medical Center - Albuquerque

Albuquerque, New Mexico, 87108-5138, United States

Location

Veterans Affairs Medical Center - Albany

Albany, New York, 12208, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

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

Rochester, New York, 14642, United States

Location

Veterans Affairs Medical Center - Cincinnati

Cincinnati, Ohio, 45220-2288, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195-9001, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428-1002, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Veterans Affairs Medical Center - Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97201-3098, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Veterans Affairs Medical Center - Charleston

Charleston, South Carolina, 29401-5799, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

University of Tennessee Cancer Institute at Methodist Central Hospital

Memphis, Tennessee, 38104, United States

Location

Veterans Affairs Medical Center - Amarillo

Amarillo, Texas, 79106, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

UMC Southwest Cancer and Research Center

Lubbock, Texas, 79415-3364, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, 78229, United States

Location

Veterans Affairs Medical Center - Temple

Temple, Texas, 76504, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84132, United States

Location

Veterans Affairs Medical Center - Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98104, United States

Location

Veterans Affairs Medical Center - Seattle

Seattle, Washington, 98108, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-5000, United States

Location

MeSH Terms

Conditions

Leukemia; Congenital Abnormalities

Interventions

Cyclosporine; fludarabine; Mycophenolic Acid; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: SWOG leukemia statistician
• Organization: SWOG statistical office

206-667-4408

Study Officials

• Peter McSweeney, MD

  Rocky Mountain Cancer Centers - Denver Midtown

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: January 27, 2003
• First Posted: January 28, 2003
• Study Start: April 1, 2003
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2006
• Last Updated: March 25, 2015
• Results First Posted: March 22, 2013

Record last verified: 2015-03

Locations

US (83)