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Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Sponsor
Eastern Cooperative Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00006008
Collaborator
National Cancer Institute (NCI) (NIH)
71
Locations
75
Duration (Months)

Study Details

Study Description

Brief Summary

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 arsenic trioxide in treating patients who have relapsed or refractory acute lymphoblastic leukemia.

Condition or Disease Intervention/Treatment Phase
  • Drug: arsenic trioxide
 Phase 2

Detailed Description

OBJECTIVES:

  • Determine the complete remission rate of patients with relapsed or refractory acute lymphoblastic leukemia treated with arsenic trioxide.

  • Determine the toxic effects of induction arsenic trioxide in this patient population.

OUTLINE: Patients are stratified according to administration schedule of arsenic trioxide (5 days a week vs 7 days a week).

Patients receive arsenic trioxide IV over 1 hour daily until bone marrow blasts are less than 5% or for a maximum of 60 days. Beginning 3-6 weeks after induction, patients achieving a complete remission receive arsenic trioxide IV over 1 hour daily either 5 days or 7 days a week for 25 days. Subsequent consolidation courses are given with 4 week treatment-free intervals between courses. Treatment continues for a maximum of 5 consolidation courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 13-40 patients will be accrued for this study within 3 years.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Arsenic Trioxide (NSC #706363) for Relapsed or Refractory Acute Lymphoblastic Leukemia
Study Start Date :
Jun 1, 2000
Actual Study Completion Date :
Sep 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Morphologically proven acute lymphoblastic leukemia (ALL)

    • Subtypes L1, L2, or L3

    • Bone marrow morphology with greater than 25% lymphoblasts

    • ALL morphology and cytochemistry with myeloid markers eligible

    • Refractory to induction therapy or relapsed following chemotherapy or autologous blood or bone marrow transplantation

    • Any number of prior relapses allowed

    • No relapse following allogeneic transplantation

    • Prior CNS leukemia allowed if treated and currently disease-free

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • ECOG 0-2
    Life expectancy:
    • At least 6 months
    Hematopoietic:
    • Not specified
    Hepatic:

    • Bilirubin no greater than 2.0 mg/dL

    • SGOT/SGPT no greater than 2 times upper limit of normal (ULN)

    • Alkaline phosphatase no greater than 2 times ULN

    Renal:
    • Creatinine no greater than 2 mg/dL
    Other:

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • No significant active infection

    • No other medical conditions that would likely decrease life expectancy

    • No other prior malignancy within the past 5 years except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • See Disease Characteristics
    Chemotherapy:
    • See Disease Characteristics
    Endocrine therapy:
    • At least 2 weeks since prior systemic corticosteroids
    Radiotherapy:
    • Not specified
    Surgery:
    • Not specified
    Other:
    • No concurrent antibiotics for active or resolving infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CCOP - Scottsdale Oncology Program Scottsdale Arizona United States 85259-5404
    2 Cancer Center and Beckman Research Institute, City of Hope Duarte California United States 91010-3000
    3 Veterans Affairs Medical Center - Palo Alto Palo Alto California United States 94304
    4 Stanford University Medical Center Stanford California United States 94305-5408
    5 CCOP - Colorado Cancer Research Program, Inc. Denver Colorado United States 80209-5031
    6 CCOP - Christiana Care Health Services Wilmington Delaware United States 19899
    7 Veterans Affairs Medical Center - Gainsville Gainesville Florida United States 32608-1197
    8 Veterans Affairs Medical Center - Miami Miami Florida United States 33125
    9 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612-9497
    10 Veterans Affairs Medical Center - Tampa (Haley) Tampa Florida United States 33612
    11 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
    12 Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia United States 30033
    13 Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois United States 60611-3013
    14 Veterans Affairs Medical Center - Lakeside Chicago Chicago Illinois United States 60611
    15 CCOP - Central Illinois Decatur Illinois United States 62526
    16 CCOP - Evanston Evanston Illinois United States 60201
    17 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61602
    18 CCOP - Carle Cancer Center Urbana Illinois United States 61801
    19 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    20 Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana United States 46202
    21 CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa United States 52403-1206
    22 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309-1016
    23 Holden Comprehensive Cancer Center at The University of Iowa Iowa City Iowa United States 52242-1009
    24 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    25 CCOP - Ochsner New Orleans Louisiana United States 70121
    26 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
    27 New England Medical Center Hospital Boston Massachusetts United States 02111
    28 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    29 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
    30 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-3731
    31 CCOP - Duluth Duluth Minnesota United States 55805
    32 Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota United States 55417
    33 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    34 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    35 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
    36 Veterans Affairs Medical Center - Omaha Omaha Nebraska United States 68105
    37 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68131
    38 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    39 Veterans Affairs Medical Center - East Orange East Orange New Jersey United States 07018-1095
    40 CCOP - Northern New Jersey Hackensack New Jersey United States 07601
    41 Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
    42 Albert Einstein Comprehensive Cancer Center Bronx New York United States 10461
    43 Veterans Affairs Medical Center - Brooklyn Brooklyn New York United States 11209
    44 Veterans Affairs Medical Center - New York New York New York United States 10010
    45 NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York United States 10016
    46 CCOP - Merit Care Hospital Fargo North Dakota United States 58122
    47 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    48 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    49 CCOP - Columbus Columbus Ohio United States 43206
    50 CCOP - Toledo Community Hospital Oncology Program Toledo Ohio United States 43623-3456
    51 CCOP - Oklahoma Tulsa Oklahoma United States 74136
    52 CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania United States 17822-2001
    53 Hahnemann University Hospital Philadelphia Pennsylvania United States 19102-1192
    54 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104-4283
    55 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
    56 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    57 University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania United States 15213-3489
    58 Veterans Affairs Medical Center - Pittsburgh Pittsburgh Pennsylvania United States 15240
    59 CCOP - MainLine Health Wynnewood Pennsylvania United States 19096
    60 CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota United States 57104
    61 Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville Tennessee United States 37212
    62 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-6838
    63 Veterans Affairs Medical Center - Madison Madison Wisconsin United States 53705
    64 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792-6164
    65 CCOP - Marshfield Medical Research and Education Foundation Marshfield Wisconsin United States 54449
    66 Marshfield Clinic Marshfield Wisconsin United States 54449
    67 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    68 Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin United States 53295
    69 MBCCOP - San Juan San Juan Puerto Rico 00927-5800
    70 Veterans Affairs Medical Center - San Juan San Juan Puerto Rico 00927-5800
    71 Pretoria Academic Hospitals Pretoria South Africa 0001

    Sponsors and Collaborators

    • Eastern Cooperative Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Mark R. Litzow, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00006008
    Other Study ID Numbers:
    • CDR0000068016
    • E-9998
    First Posted:
    Nov 5, 2003
    Last Update Posted:
    Jun 21, 2013
    Last Verified:
    Aug 1, 2002
    Keywords provided by , ,
    recurrent adult acute lymphoblastic leukemia
    L1 adult acute lymphoblastic leukemia
    L2 adult acute lymphoblastic leukemia
    L3 adult acute lymphoblastic leukemia
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid
    Arsenic Trioxide

    Study Results

    No Results Posted as of Jun 21, 2013