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S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

This study is currently recruiting participants.
Verified January 2013 by Southwest Oncology Group
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00551460
First received: October 30, 2007
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination chemotherapy may be more effective in treating promyelocytic leukemia.

PURPOSE: This phase II trial is studying how well giving gemtuzumab together with combination chemotherapy works in treating patients with previously untreated promyelocytic leukemia.


Condition Intervention Phase
Leukemia
 Drug: arsenic trioxide
Drug: gemtuzumab ozogamicin
Drug: mercaptopurine
Drug: methotrexate
Drug: tretinoin
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: S0535, A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Continuous complete remission at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Mortality rate at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: November 2007
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment

Induction:

ATRA 45mg/m2 PO D1-CR Gemtuzumab Ozogamicin 9 mg/m2 IV D1 Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR

Consolidation 1 and 2:

Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest

Consolidation 2 and 3:

ATRA 45 mg/m2 PO D1-7 Daunomycin 50 mg/m2/d IV D1-3

Consolidation 5 and 6:

GO 9mg/m2 IV D1

Maintenance:

ATRA 45 mg/m2/d PO D1-7 every 14 days 6-MP 60 mg/m2/d PO daily for 1 year Methotrexate 20 mg/m2 PO once/wk for 1 year

 Drug: arsenic trioxide Drug: gemtuzumab ozogamicin Drug: mercaptopurine Drug: methotrexate Drug: tretinoin

Detailed Description:

OBJECTIVES:

  • To assess the event-free survival and death during the first six weeks in patients with previously untreated, high-risk acute promyelocytic leukemia treated with a combined regimen of tretinoin, arsenic trioxide, and gemtuzumab ozogamicin.
  • To estimate the frequency and severity of toxicities of this regimen in this group of patients.
  • To investigate the molecular response rate utilizing this regimen in high-risk patients.

OUTLINE:

  • Induction chemotherapy: Patients receive oral tretinoin twice daily beginning on day 1 until CR (up to 90 days), gemtuzumab ozogamicin IV over 2 hours on day 1, and arsenic trioxide IV over 2 hours 5 days a week beginning on day 10 until CR (up to 60 days) in the absence of disease progression or unacceptable toxicity. Patients achieving A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status proceed to consolidation therapy after maintaining B1 peripheral blood status for ≥ 7 days.

  • Consolidation therapy: Beginning between 2-8 weeks after documentation of complete response (CR), patients receive consolidation therapy.

    • Consolidation courses 1 and 2: Patients receive arsenic trioxide IV over 2 hours 5 days a week for 5 weeks. Treatment repeats every 7 weeks for up to 2 courses. Patients remaining in A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status continue with consolidation courses 3 and 4.
    • Consolidation courses 3 and 4: Within 4 weeks of completing consolidation course 2, patients receive oral tretinoin twice daily on days 1-7 and daunomycin IV bolus or over 1 hour on days 1-3. Within 2-8 weeks after recovery to B1 peripheral blood status, patients receive consolidation course 4 as in course 3. Patients who remain in B1 peripheral blood and C1 extramedullary disease status continue on consolidation courses 5 and 6.
    • Consolidation courses 5 and 6: Beginning between 2-8 weeks after recovery to B1 peripheral blood status, patients receive gemtuzumab IV over 2 hours on day 1. Between 2-8 weeks after recovery to B1 peripheral blood status, patients receive consolidation course 6 as in course 5. Patients who remain in A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status proceed to maintenance therapy.
  • Maintenance therapy: Beginning 2-8 weeks after recovery of blood counts, patients receive oral tretinoin twice daily on days 1-7 every other week for 1 year, oral mercaptopurine once daily for 1 year, and oral methotrexate once weekly for 1 year.

Patients undergo bone marrow aspirates and biopsies periodically during study. Samples are analyzed for cytogenetics by fluorescence in situ hybridization (FISH) and for PML-RARα by polymerase chain reaction (PCR).

After completion of study treatment, patients are evaluated at 3, 6, 9, 12, 18, 24, and 36 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Morphologically confirmed acute promyelocytic leukemia (APL) based on bone marrow examination

    • APL-RARα-negative by RT-PCR are not eligible
  • High-risk disease, defined as WBC > 100,000/mm^3
  • Bone marrow specimens must be made available for cytogenetic studies

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prolonged QTc > 0.47 sec
  • 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 stage II cancer from which the patients is currently in complete remission

PRIOR CONCURRENT THERAPY:

  • No prior systemic chemotherapy for acute leukemia

    • At least 3 days since prior tretinoin (ATRA) allowed
  • Prior hydroxyurea, corticosteroids, or leukapheresis to control high cell counts allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00551460

Contacts
Contact: Sandi J Fredette 2106148808 ext 1002 sfredette@swog.org
Contact: Dana Sparks, MAT 2106148808 ext 1004 dsparks@swog.org

  Hide Study Locations
Locations
United States, California
Sutter Cancer Center at Roseville Medical Center Recruiting
Roseville, California, United States, 95661
Contact: Clinical Trials Office - Sutter Cancer Center     916-454-6595        
Sutter Cancer Center Recruiting
Sacramento, California, United States, 95816
Contact: Clinical Trial Office - Sutter Cancer Center     916-454-6595        
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305-5824
Contact: Clinical Trials Office - Stanford Cancer Center     650-498-7061     cctoffice@stanford.edu    
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Philip J. Stella, MD     734-712-1000        
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center     302-645-3171        
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services     302-623-4450        
United States, Florida
M.D. Anderson Cancer Center at Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Jose E. Sarriera     321-841-1893        
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Recruiting
Tampa, Florida, United States, 33612-9497
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese     800-456-7121     canceranswers@moffitt.org    
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Clinical Trials Office - Saint Alphonsus Cancer Care Center     208-367-7954        
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer     312-695-1301     cancer@northwestern.edu    
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
Hematology and Oncology Associates Recruiting
Chicago, Illinois, United States, 60611
Contact: Clinical Trails Office - Hematology and Oncology Associates     312-695-1301        
Kellogg Cancer Care Center Recruiting
Highland Park, Illinois, United States, 60035
Contact: Olga Frankfurt     847-480-3800        
Provena St. Mary's Regional Cancer Center - Kankakee Recruiting
Kankakee, Illinois, United States, 60901
Contact: Olga Frankfurt     815-937-8780        
North Shore Oncology and Hematology Associates, Limited - Libertyville Recruiting
Libertyville, Illinois, United States, 60048
Contact: Olga Frankfurt     847-367-6781        
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center     708-226-4357        
Cancer Care and Hematology Specialists of Chicagoland - Niles Recruiting
Niles, Illinois, United States, 60714
Contact: Olga Frankfurt     847-827-9060        
Swedish-American Regional Cancer Center Recruiting
Rockford, Illinois, United States, 61104-2315
Contact: Clinical Trials Office - Swedish-American Regional Cancer Cent     815-489-4413        
Hematology Oncology Associates - Skokie Recruiting
Skokie, Illinois, United States, 60076
Contact: Olga Frankfurt     847-568-9930        
United States, Indiana
Fort Wayne Medical Oncology and Hematology Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Sreenivasa R. Nattam, MD     260-484-8830        
United States, Iowa
Mercy Medical Center - Sioux City Recruiting
Sioux City, Iowa, United States, 51102
Contact: Donald B. Wender, MD, PhD     712-252-0088        
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender, MD, PhD     712-252-0088        
St. Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD     712-252-0088        
United States, Kansas
Cancer Center of Kansas, PA - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Providence Medical Center Recruiting
Kansas City, Kansas, United States, 66112
Contact: Rakesh Gaur, MD     913-948-5588        
Cancer Center of Kansas, PA - Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Liberal Recruiting
Liberal, Kansas, United States, 67901
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - McPherson Recruiting
McPherson, Kansas, United States, 67460
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Saint Luke's Hospital - South Recruiting
Overland Park, Kansas, United States, 66213
Contact: Rakesh Gaur, MD     913-948-5588        
Menorah Medical Center Recruiting
Overland Park, Kansas, United States, 66209
Contact: Rakesh Gaur, MD     913-948-5588        
Cancer Center of Kansas, PA - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
CCOP - Kansas City Recruiting
Prairie Village, Kansas, United States, 66208
Contact: Rakesh Gaur, MD     913-948-5588        
Cancer Center of Kansas, PA - Pratt Recruiting
Pratt, Kansas, United States, 67124
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Salina Recruiting
Salina, Kansas, United States, 67401
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
CCOP - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Associates in Womens Health, PA - North Review Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Via Christi Cancer Center at Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Wesley Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit     800-888-8823        
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce     410-955-8804     jhcccro@jhmi.edu    
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Stephen S. Grubbs, MD     302-366-1200        
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center     617-667-9925        
Dana-Farber/Brigham and Women's Cancer Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Clinical Trials Office     617-724-5200        
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Daniel J. DeAngelo     617-632-3474        
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital     877-726-5130        
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109-0942
Contact: Clinical Trials Office - University of Michigan Comprehensive     800-865-1125        
Saint Joseph Mercy Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Philip J. Stella, MD     734-712-1000        
CCOP - Michigan Cancer Research Consortium Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella, MD     734-712-1000        
Battle Creek Health System Cancer Care Center Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Gilbert D.A. Padula     616-966-8000        
Mecosta County Medical Center Recruiting
Big Rapids, Michigan, United States, 49307
Contact: Gilbert D.A. Padula     231-796-8691        
Oakwood Cancer Center at Oakwood Hospital and Medical Center Recruiting
Dearborn, Michigan, United States, 48123-2500
Contact: Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp     313-593-8090        
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute     313-576-9363        
Green Bay Oncology, Limited - Escanaba Recruiting
Escanaba, Michigan, United States, 49431
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center     810-762-8057        
CCOP - Grand Rapids Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D.A. Padula     616-391-1230        
Lacks Cancer Center at Saint Mary's Health Care Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D.A. Padula     616-752-5222        
Butterworth Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D.A. Padula     616-391-2799        
Van Elslander Cancer Center at St. John Hospital and Medical Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo     313-343-3166        
Dickinson County Healthcare System Recruiting
Iron Mountain, Michigan, United States, 49801
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
Foote Memorial Hospital Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip J. Stella, MD     734-712-1000        
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord, MD     269-373-7458        
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center     269-373-7458        
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord, MD     269-373-7458        
Sparrow Regional Cancer Center Recruiting
Lansing, Michigan, United States, 48912-1811
Contact: Clinical Trials Office - Sparrow Regional Cancer Center     517-364-2890        
St. Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella, MD     734-712-1000        
Mercy General Health Partners Recruiting
Muskegon, Michigan, United States, 49444
Contact: Gilbert D.A. Padula     231-672-2000        
St. Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341-2985
Contact: Philip J. Stella, MD     734-712-1000        
Mercy Regional Cancer Center at Mercy Hospital Recruiting
Port Huron, Michigan, United States, 48060
Contact: Philip J. Stella, MD     734-712-1000        
Spectrum Health Reed City Hospital Recruiting
Reed City, Michigan, United States, 49677
Contact: Gilbert D.A. Padula     231-832-3271        
Seton Cancer Institute at Saint Mary's - Saginaw Recruiting
Saginaw, Michigan, United States, 48601
Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw     989-776-8411        
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Gilbert D.A. Padula     231-935-6202        
St. John Macomb Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella, MD     734-712-1000        
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Patrick J. Flynn, MD     612-884-6300        
Mercy and Unity Cancer Center at Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Patrick J. Flynn, MD     612-884-6300        
Duluth Clinic Cancer Center - Duluth Recruiting
Duluth, Minnesota, United States, 55805-1983
Contact: Clinical Trials Office - Duluth Clinic Cancer Center - Duluth     218-786-3308        
CCOP - Duluth Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel Nikcevich, MD, PhD     218-786-3625        
Miller - Dwan Medical Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel Nikcevich, MD, PhD     218-786-3625        
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Clinical Trials Office - Fairview Southdale Hospital     612-625-3650        
Mercy and Unity Cancer Center at Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Patrick J. Flynn, MD     612-884-6300        
Hutchinson Area Health Care Recruiting
Hutchinson, Minnesota, United States, 55350
Contact: Patrick J. Flynn, MD     612-884-6300        
HealthEast Cancer Care at St. John's Hospital Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Patrick J. Flynn, MD     612-884-6300        
Minnesota Oncology - Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Patrick J. Flynn, MD     612-884-6300        
Hennepin County Medical Center - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Clinical Trials Office - Hennepin County Medical Center - Minn     612-873-5911        
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Clinical Trials Office - Virginia Piper Cancer Institute     612-863-5654        
New Ulm Medical Center Recruiting
New Ulm, Minnesota, United States, 56073
Contact: Patrick J. Flynn, MD     612-884-6300        
Humphrey Cancer Center at North Memorial Outpatient Center Recruiting
Robbinsdale, Minnesota, United States, 55422-2900
Contact: Clinical Trials Office - Humphrey Cancer Center at North Memor     763-520-1893        
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
CCOP - Metro-Minnesota Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn, MD     612-884-6300        
Park Nicollet Cancer Center Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn, MD     612-884-6300        
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Patrick J. Flynn, MD     612-884-6300        
St. Francis Cancer Center at St. Francis Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Patrick J. Flynn, MD     612-884-6300        
Regions Hospital Cancer Care Center Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Clinical Trials Office - Regions Hospital Cancer Care Center     651-254-1517        
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Patrick J. Flynn, MD     612-884-6300        
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Patrick J. Flynn, MD     612-884-6300        
Willmar Cancer Center at Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Patrick J. Flynn, MD     612-884-6300        
Minnesota Oncology - Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Patrick J. Flynn, MD     612-884-6300        
United States, Mississippi
University of Mississippi Cancer Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: Carolyn L. Bigelow     601-984-5590        
United States, Missouri
Heartland Hematology Oncology Associates, Incorporated Recruiting
Kansas City, Missouri, United States, 64118
Contact: Rakesh Gaur, MD     913-948-5588        
Research Medical Center Recruiting
Kansas City, Missouri, United States, 64132
Contact: Rakesh Gaur, MD     913-948-5588        
North Kansas City Hospital Recruiting
Kansas City, Missouri, United States, 64116
Contact: Rakesh Gaur, MD     913-948-5588        
Saint Luke's Cancer Institute at Saint Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: Rakesh Gaur, MD     913-948-5588        
Saint Luke's East - Lee's Summit Recruiting
Lee's Summit, Missouri, United States, 64086
Contact: Rakesh Gaur, MD     913-948-5588        
Parvin Radiation Oncology Recruiting
Liberty, Missouri, United States, 64068
Contact: Rakesh Gaur, MD     913-948-5588        
Saint Joseph Oncology, Incorporated Recruiting
Saint Joseph, Missouri, United States, 64507
Contact: Rakesh Gaur, MD     913-948-5588        
Heartland Regional Medical Center Recruiting
Saint Joseph, Missouri, United States, 64506
Contact: Rakesh Gaur, MD     913-948-5588        
Saint Louis University Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Clinical Trials Office - Saint Louis University Cancer Center     314-977-4440        
United States, Montana
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown     800-996-2663     research@billingsclinic.org    
St. Vincent Healthcare Cancer Care Services Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
CCOP - Montana Cancer Consortium Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
Hematology-Oncology Centers of the Northern Rockies - Billings Recruiting
Billings, Montana, United States, 59102
Contact: Benjamin T. Marchello, MD     406-238-6290        
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD     406-238-6290        
St. James Healthcare Cancer Care Recruiting
Butte, Montana, United States, 59701
Contact: Benjamin T. Marchello, MD     406-238-6290        
Sletten Cancer Institute at Benefis Healthcare Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD     406-238-6290        
Great Falls Clinic - Main Facility Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD     406-238-6290        
St. Peter's Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello, MD     406-238-6290        
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
Glacier Oncology, PLLC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
Kalispell Medical Oncology at KRMC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
Montana Cancer Specialists at Montana Cancer Center Recruiting
Missoula, Montana, United States, 59807-7877
Contact: Clinical Trials Office - Montana Cancer Specialists at Montana     406-238-6962        
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Recruiting
Missoula, Montana, United States, 59807
Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick     406-329-7029        
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ     800-999-5465        
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo     856-325-6757        
United States, New York
Monter Cancer Center of the North Shore-LIJ Health System Recruiting
Lake Success, New York, United States, 11042
Contact: Jonathan E. Kolitz, MD     516-562-8970        
CCOP - North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Jonathan E. Kolitz, MD     516-562-8970        
Don Monti Comprehensive Cancer Center at North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Clinical Trials Office - Don Monti Comprehensive Cancer Center     516-734-8900        
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Jonathan E. Kolitz, MD     516-562-8970        
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi     315-464-5476        
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente     877-668-0683        
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000        
Kinston Medical Specialists Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD     252-559-2200 ext 201        
Rutherford Hospital Recruiting
Rutherfordton, North Carolina, United States, 28139
Contact: James D. Bearden, MD     864-560-6812        
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service     866-627-7616     Jamesline@osumc.edu    
St. Rita's Medical Center Recruiting
Lima, Ohio, United States, 45801
Contact: Clinical Trials Office - St. Rita's Medical Center     419-226-9617        
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute     570-271-5251        
Geisinger Hazleton Cancer Center Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: Edward J. Gorak, II     570-459-2901        
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers     800-474-9892        
Geisinger Medical Group - Scenery Park Recruiting
State College, Pennsylvania, United States, 16801
Contact: Edward J. Gorak, II     814-231-4560        
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce     570-271-5251        
United States, South Carolina
AnMed Cancer Center Recruiting
Anderson, South Carolina, United States, 29621
Contact: Clinical Trials Office - AnMed Cancer Center     864-512-1000        
Hollings Cancer Center at Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni     843-792-9321        
Bon Secours St. Francis Health System Recruiting
Greenville, South Carolina, United States, 29601
Contact: Clinical Trails Office - Bon Secours St. Francis Health System     864-255-1713        
CCOP - Upstate Carolina Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Clinical Trials Office - CCOP - Upstate Carolina     800-486-5941        
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Clinical Trials Office - Gibbs Regional Cancer Center     800-486-5941        
United States, Utah
American Fork Hospital Recruiting
American Fork, Utah, United States, 84003
Contact: Julie D. Asch     801-855-3300        
Sandra L. Maxwell Cancer Center Recruiting
Cedar City, Utah, United States, 84720
Contact: Julie D. Asch     801-585-0550        
Logan Regional Hospital Recruiting
Logan, Utah, United States, 84321
Contact: Julie D. Asch     435-716-1000        
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Julie D. Asch     801-507-3800        
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Recruiting
Ogden, Utah, United States, 84403
Contact: Clinical Trials Office - McKay-Dee Hospital Center     801-387-7426        
Utah Valley Regional Medical Center - Provo Recruiting
Provo, Utah, United States, 84604
Contact: Clinical Trials Office - Utah Valley Regional Medical Center -     801-357-7965        
Dixie Regional Medical Center - East Campus Recruiting
Saint George, Utah, United States, 84770
Contact: Clinical Trials Office - Dixie Regional Medical Center - East     435-688-4167        
LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
Contact: Julie D. Asch     801-408-1819        
Utah Cancer Specialists at UCS Cancer Center Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Julie D. Asch     801-269-0231        
United States, Washington
Island Hospital Cancer Care Center at Island Hospital Recruiting
Anacortes, Washington, United States, 98221
Contact: Saul E. Rivkin, MD     206-386-2441        
St. Joseph Cancer Center Recruiting
Bellingham, Washington, United States, 98225
Contact: Saul E. Rivkin, MD     206-386-2441        
Olympic Hematology and Oncology Recruiting
Bremerton, Washington, United States, 98310
Contact: Saul E. Rivkin, MD     206-386-2441        
Highline Medical Center Cancer Center Recruiting
Burien, Washington, United States, 98166
Contact: Saul E. Rivkin, MD     206-386-2441        
Swedish Medical Center - Issaquah Campus Recruiting
Issaquah, Washington, United States, 98029
Contact: Saul E. Rivkin, MD     206-386-2441        
Columbia Basin Hematology Recruiting
Kennewick, Washington, United States, 99336
Contact: Saul E. Rivkin, MD     206-386-2441        
Skagit Valley Hospital Cancer Care Center Recruiting
Mount Vernon, Washington, United States, 98274
Contact: Saul E. Rivkin, MD     206-386-2441        
Harrison Poulsbo Hematology and Onocology Recruiting
Poulsbo, Washington, United States, 98370
Contact: Saul E. Rivkin, MD     206-386-2441        
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Saul E. Rivkin, MD     206-386-2441        
Minor and James Medical, PLLC Recruiting
Seattle, Washington, United States, 98104
Contact: Saul E. Rivkin, MD     206-386-2441        
Group Health Central Hospital Recruiting
Seattle, Washington, United States, 98112
Contact: Clinical Trials Office - Group Health Central Hospital     206-287-2900        
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Saul E. Rivkin, MD     206-386-2441        
Polyclinic First Hill Recruiting
Seattle, Washington, United States, 98122
Contact: Saul E. Rivkin, MD     206-386-2441        
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Recruiting
Seattle, Washington, United States, 98122-4307
Contact: Saul E. Rivkin, MD     206-386-2441        
University Cancer Center at University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Saul E. Rivkin, MD     206-386-2441        
North Puget Oncology at United General Hospital Recruiting
Sedro-Woolley, Washington, United States, 98284
Contact: Saul E. Rivkin, MD     206-386-2441        
Evergreen Hematology and Oncology, PS Recruiting
Spokane, Washington, United States, 99218
Contact: Saul E. Rivkin, MD     206-386-2441        
Cancer Care Northwest - Spokane South Recruiting
Spokane, Washington, United States, 99202
Contact: Clinical Trials Office - Cancer Care Northwest - Spokane South     509-228-1083        
Wenatchee Valley Medical Center Recruiting
Wenatchee, Washington, United States, 98801-2028
Contact: Clinical Trials Office - Wenatchee Valley Medical Center     509-665-5800        
United States, West Virginia
Mary Babb Randolph Cancer Center at West Virginia University Hospitals Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Mehdi Hamadani     304-293-4500        
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer     920-433-8889        
St. Mary's Hospital Medical Center - Green Bay Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
Green Bay Oncology, Limited at St. Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
Holy Family Memorial Medical Center Cancer Care Center Recruiting
Manitowoc, Wisconsin, United States, 54221-1450
Contact: Clinical Trials Office - Holy Family Memorial Medical Center C     920-320-2749        
Bay Area Cancer Care Center at Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
Green Bay Oncology, Limited - Oconto Falls Recruiting
Oconto Falls, Wisconsin, United States, 54154
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
St. Nicholas Hospital Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
Green Bay Oncology, Limited - Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
United States, Wyoming
Rocky Mountain Oncology Recruiting
Casper, Wyoming, United States, 82609
Contact: Benjamin T. Marchello, MD     406-238-6290        
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Jeffrey E. Lancet, MD H. Lee Moffitt Cancer Center and Research Institute
Study Chair: Rami Komrokji, MD H. Lee Moffitt Cancer Center and Research Institute
Study Chair: Cheryl L. Willman, MD University of New Mexico Cancer Center
Study Chair: 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: NCT00551460     History of Changes
Other Study ID Numbers: CDR0000572619, S0535, U10CA032102
Study First Received: October 30, 2007
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
adult acute promyelocytic leukemia (M3)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
untreated adult acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
6-Mercaptopurine
Methotrexate
Arsenic trioxide
Gemtuzumab
Tretinoin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Folic Acid Antagonists
Antirheumatic Agents
Keratolytic Agents

ClinicalTrials.gov processed this record on May 23, 2013