506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- Registration Number
- NCT00003545
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
Phase II trial to study the effectiveness of 506U78 in treating patients with refractory or relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
- Detailed Description
OBJECTIVES:
I. Determine the complete and partial remission rates, as well as the remission duration, in patients with refractory or relapsed T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma receiving 506U78 on an alternate day schedule (days 1, 3, 5).
II. Determine the safety and toxicity of 506U78 administered on this schedule to this patient population.
OUTLINE:
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. If residual leukemia/lymphoma is present on day 22, then patients receive a second course of 506U78. If day 22 marrow is hypocellular, then a repeat bone marrow biopsy should be obtained on day 29 to assess response. For day 22 or 29 marrow that is in complete response, patients receive 506U78 for two more courses on days 1, 3, and 5, administered every 21 days. Patients are followed every 3 month for 1 year, then every 6 months for a maximum of 10 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm I nelarabine Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. If residual leukemia/lymphoma is present on day 22, then patients receive a second course of 506U78. If day 22 marrow is hypocellular, then a repeat bone marrow biopsy should be obtained on day 29 to assess response. For day 22 or 29 marrow that is in complete response, patients receive 506U78 for two more courses on days 1, 3, and 5, administered every 21 days. Patients are followed every 3 month for 1 year, then every 6 months for a maximum of 10 years.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (91)
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
Veterans Affairs Medical Center - Biloxi
🇺🇸Biloxi, Mississippi, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Stanford University
🇺🇸Stanford, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Dwight David Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
CCOP - Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Texas Tech University Health Science Center
🇺🇸Lubbock, Texas, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
🇺🇸Phoenix, Arizona, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Oregon Cancer Center
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - West Los Angeles
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States