Clincosm LogoSign in Get a demo

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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00003545
Collaborator
Southwest Oncology Group (Other)
35
Enrollment
91
Locations
1
Arm
0.4
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  1. 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).

  2. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of 506U78 in Patients With Refractory or Relapsed T-Lineage Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphomas (LBL)
Study Start Date :
Aug 1, 1998
Actual Primary Completion Date :
Mar 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

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.

Drug: nelarabine

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    PATIENT CHARACTERISTICS:

    • Age: 16 and over

    • Bilirubin no greater than 2 times upper limit of normal (unless due to leukemia)

    • Creatinine clearance at least 50 mL/min (unless due to leukemia)

    • 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

    • No history of seizure disorder

    • Not pregnant or nursing

    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:

    • No concurrent erythropoietin

    • No other concurrent chemotherapy

    • No concurrent dexamethasone or other steroidal antiemetics

    • No concurrent hormone therapy, except for non-disease-related conditions

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MBCCOP - Gulf Coast Mobile Alabama United States 36688
    2 CCOP - Greater Phoenix Phoenix Arizona United States 85006-2726
    3 Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix Arizona United States 85012
    4 Veterans Affairs Medical Center - Tucson Tucson Arizona United States 85723
    5 Arizona Cancer Center Tucson Arizona United States 85724
    6 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    7 Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock Arkansas United States 72205
    8 Cancer Center and Beckman Research Institute, City of Hope Duarte California United States 91010-3000
    9 Veterans Affairs Medical Center - Long Beach Long Beach California United States 90822
    10 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
    11 Veterans Affairs Medical Center - West Los Angeles Los Angeles California United States 90073
    12 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    13 Veterans Affairs Outpatient Clinic - Martinez Martinez California United States 94553
    14 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
    15 Chao Family Comprehensive Cancer Center Orange California United States 92868
    16 University of California Davis Medical Center Sacramento California United States 95817
    17 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
    18 Stanford University Stanford California United States 94305
    19 David Grant Medical Center Travis Air Force Base California United States 94535
    20 University of Colorado Cancer Center Denver Colorado United States 80010
    21 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
    22 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
    23 Dwight David Eisenhower Army Medical Center Fort Gordon Georgia United States 30905-5650
    24 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
    25 MBCCOP - University of Illinois at Chicago Chicago Illinois United States 60612-7323
    26 CCOP - Central Illinois Decatur Illinois United States 62526
    27 Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois United States 60141
    28 Loyola University Medical Center Maywood Illinois United States 60153
    29 University of Kansas Medical Center Kansas City Kansas United States 66160-7357
    30 CCOP - Wichita Wichita Kansas United States 67214-3882
    31 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
    32 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40511-1093
    33 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    34 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    35 Tulane University School of Medicine New Orleans Louisiana United States 70112
    36 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71130-3932
    37 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71130
    38 Boston Medical Center Boston Massachusetts United States 02118
    39 Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts United States 02130
    40 Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan United States 48105
    41 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
    42 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752
    43 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    44 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
    45 Henry Ford Hospital Detroit Michigan United States 48202
    46 CCOP - Grand Rapids Clinical Oncology Program Grand Rapids Michigan United States 49503
    47 Providence Hospital - Southfield Southfield Michigan United States 48075-9975
    48 CCOP - Duluth Duluth Minnesota United States 55805
    49 Veterans Affairs Medical Center - Biloxi Biloxi Mississippi United States 39531-2410
    50 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    51 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
    52 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
    53 Veterans Affairs Medical Center - Kansas City Kansas City Missouri United States 64128
    54 CCOP - Kansas City Kansas City Missouri United States 64131
    55 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110-0250
    56 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
    57 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    58 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    59 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
    60 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
    61 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    62 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
    63 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45219
    64 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
    65 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    66 CCOP - Columbus Columbus Ohio United States 43206
    67 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
    68 CCOP - Dayton Kettering Ohio United States 45429
    69 CCOP - Toledo Community Hospital Oncology Program Toledo Ohio United States 43623-3456
    70 Veterans Affairs Medical Center - Oklahoma City Oklahoma City Oklahoma United States 73104
    71 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73190
    72 Oregon Cancer Center Portland Oregon United States 97201-3098
    73 Veterans Affairs Medical Center - Portland Portland Oregon United States 97207
    74 CCOP - Columbia River Program Portland Oregon United States 97213
    75 CCOP - Greenville Greenville South Carolina United States 29615
    76 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    77 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    78 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    79 University of Texas Medical Branch Galveston Texas United States 77555-0209
    80 Texas Tech University Health Science Center Lubbock Texas United States 79423
    81 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78284-7811
    82 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78284
    83 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
    84 CCOP - Scott and White Hospital Temple Texas United States 76508
    85 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    86 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
    87 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
    88 Swedish Cancer Institute Seattle Washington United States 98104
    89 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
    90 CCOP - Northwest Tacoma Washington United States 98405-0986
    91 Madigan Army Medical Center Tacoma Washington United States 98431-5000

    Sponsors and Collaborators

    • National Cancer Institute (NCI)
    • Southwest Oncology Group

    Investigators

    • Study Chair: Daniel DeAngelo, MD, PhD, Dana-Farber Cancer Institute
    • Study Chair: Steven E. Coutre, MD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00003545
    Other Study ID Numbers:
    • NCI-2012-01840
    • CLB-19801
    • SWOG-C19801
    • CDR0000066600
    First Posted:
    Feb 16, 2004
    Last Update Posted:
    Feb 5, 2013
    Last Verified:
    Apr 1, 2007
    Keywords provided by National Cancer Institute (NCI)
    recurrent childhood acute lymphoblastic leukemia
    recurrent childhood lymphoblastic lymphoma
    recurrent adult acute lymphoblastic leukemia
    T-cell childhood acute lymphoblastic leukemia
    T-cell adult acute lymphoblastic leukemia
    recurrent adult lymphoblastic lymphoma
    recurrent adult T-cell leukemia/lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid

    Study Results

    No Results Posted as of Feb 5, 2013