Clinical Trial: 506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Southwest Oncology Group
Cancer and Leukemia Group B
Information provided by: National Cancer Institute (NCI)


RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients with refractory or relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma.

Condition Treatment or Intervention Phase
recurrent adult lymphoblastic lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent childhood lymphoblastic lymphoma
T-cell childhood acute lymphoblastic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
T-cell adult acute lymphoblastic leukemia
 Drug: U78
Phase II

MedlinePlus related topics:  Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma;   Viral Infections

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of 506U78 for Refractory or Relapsed T-Cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Further Study Details: 

Study start: April 2000

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.

PROTOCOL 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.

PROJECTED ACCRUAL: Approximately 18-35 patients will be accrued for this study within 2.5-3 years, at a rate of 12-15 patients per year.


Ages Eligible for Study:  16 Years and above


PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed diagnosis of T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) Leukemia or lymphoma cells should express at least two of the following cell surface antigens: CD1a, CD2, CD3 (surface or cytoplasmic), CD4, CD5, CD7, and CD8 Leukemia cells should be negative for myeloperoxidase or Sudan Black B If the only T cell markers present are CD4 and CD7, the leukemic cells should be demonstrated to lack the myeloid markers CD33 and/or CD13 Refractory to at least one induction treatment regimen or in first or later relapse after achieving a complete remission No CNS leukemia or lymphoma requiring intrathecal or craniospinal radiotherapy --Prior/Concurrent Therapy-- Biologic therapy: No concurrent erythropoietin Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: No concurrent dexamethasone or other steroidal antiemetics No concurrent hormone therapy, except for non-disease-related conditions Radiotherapy: See Disease Characteristics Surgery: Not specified --Patient Characteristics-- Age: 16 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (unless due to leukemia) Renal: Creatinine clearance at least 50 mL/min (unless due to leukemia) Neurologic: No neurologic toxicity of grade 3 or greater during prior treatment of ALL/LBL No preexisting neuropathy of grade 2 or greater regardless of causality Other: No history of seizure disorder Not pregnant or nursing Fertile patients must use effective contraception

Location Information

      MBCCOP - Gulf Coast, Mobile,  Alabama,  36688,  United States

      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States

      CCOP - Greater Phoenix, Phoenix,  Arizona,  85006-2726,  United States

      Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix,  Arizona,  85012,  United States

      Veterans Affairs Medical Center - Tucson, Tucson,  Arizona,  85723,  United States

      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States

      Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock,  Arkansas,  72205,  United States

      Cancer Center and Beckman Research Institute, City of Hope, Duarte,  California,  91010-3000,  United States

      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States

      CCOP - Santa Rosa Memorial Hospital, Santa Rosa,  California,  95403,  United States

      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States

      David Grant Medical Center, Travis Air Force Base,  California,  94535,  United States

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

      Stanford University, Stanford,  California,  94305,  United States

      University of California Davis Medical Center, Sacramento,  California,  95817,  United States

      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States

      Veterans Affairs Medical Center - Long Beach, Long Beach,  California,  90822,  United States

      Veterans Affairs Medical Center - West Los Angeles, Los Angeles,  California,  90073,  United States

      Veterans Affairs Outpatient Clinic - Martinez, Martinez,  California,  94553,  United States

      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States

      Veterans Affairs Medical Center - Denver, Denver,  Colorado,  80220,  United States

      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States

      Dwight David Eisenhower Army Medical Center, Fort Gordon,  Georgia,  30905-5650,  United States

      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States

      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States

      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612-7323,  United States

      Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines,  Illinois,  60141,  United States

      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States

      University of Kansas Medical Center, Kansas City,  Kansas,  66160-7357,  United States

      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States

      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States

      Veterans Affairs Medical Center - Lexington, Lexington,  Kentucky,  40511-1093,  United States

      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States

      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States

      Tulane University School of Medicine, New Orleans,  Louisiana,  70112,  United States

      Veterans Affairs Medical Center - Shreveport, Shreveport,  Louisiana,  71130,  United States

      Boston Medical Center, Boston,  Massachusetts,  02118,  United States

      Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain,  Massachusetts,  02130,  United States

      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States

      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States

      CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids,  Michigan,  49503,  United States

      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States

      Providence Hospital - Southfield, Southfield,  Michigan,  48075-9975,  United States

      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0752,  United States

      Veterans Affairs Medical Center - Ann Arbor, Ann Arbor,  Michigan,  48105,  United States

      Veterans Affairs Medical Center - Detroit, Detroit,  Michigan,  48201-1932,  United States

      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States

      Keesler Medical Center - Keesler AFB, Keesler AFB,  Mississippi,  39534-2576,  United States

      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States

      Veterans Affairs Medical Center - Biloxi, Biloxi,  Mississippi,  39531-2410,  United States

      Veterans Affairs Medical Center - Jackson, Jackson,  Mississippi,  39216,  United States

      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States

      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States

      St. Louis University Health Sciences Center, Saint Louis,  Missouri,  63110-0250,  United States

      Veterans Affairs Medical Center - Kansas City, Kansas City,  Missouri,  64128,  United States

      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States

New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States

      Veterans Affairs Medical Center - Albuquerque, Albuquerque,  New Mexico,  87108-5138,  United States

New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States

North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States

      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45219,  United States

      CCOP - Columbus, Columbus,  Ohio,  43206,  United States

      CCOP - Dayton, Kettering,  Ohio,  45429,  United States

      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States

      Veterans Affairs Medical Center - Cincinnati, Cincinnati,  Ohio,  45220-2288,  United States

      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428,  United States

      University of Oklahoma Health Sciences Center, Oklahoma City,  Oklahoma,  73190,  United States

      Veterans Affairs Medical Center - Oklahoma City, Oklahoma City,  Oklahoma,  73104,  United States

      CCOP - Columbia River Program, Portland,  Oregon,  97213,  United States

      Oregon Cancer Center, Portland,  Oregon,  97201-3098,  United States

      Veterans Affairs Medical Center - Portland, Portland,  Oregon,  97207,  United States

South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States

      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States

      Brooke Army Medical Center, Fort Sam Houston,  Texas,  78234,  United States

      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States

      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States

      Texas Tech University Health Science Center, Lubbock,  Texas,  79423,  United States

      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States

      University of Texas Medical Branch, Galveston,  Texas,  77555-0209,  United States

      Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,  Texas,  78284,  United States

      Veterans Affairs Medical Center - Temple, Temple,  Texas,  76504,  United States

      Huntsman Cancer Institute, Salt Lake City,  Utah,  84112,  United States

      Veterans Affairs Medical Center - Salt Lake City, Salt Lake City,  Utah,  84148,  United States

      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States

      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States

      Madigan Army Medical Center, Tacoma,  Washington,  98431-5000,  United States

      Swedish Cancer Institute, Seattle,  Washington,  98104,  United States

      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98108,  United States

Study chairs or principal investigators

Richard L. Schilsky,  Study Chair,  Cancer and Leukemia Group B   
Steven E. Coutre,  Study Chair

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066600; CLB-19801
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999 Identifier:  NCT00003545
Health Authority: United States: Federal Government processed this record on 2005-04-08

Cache Date: April 9, 2005