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A Phase II Trial of Arsenic Trioxide (NSC #706363) for Relapsed or Refractory Acute Lymphoblastic Leukemia

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Trial of Arsenic Trioxide (NSC #706363) for Relapsed or Refractory Acute Lymphoblastic Leukemia


- 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.

Inclusion Criteria


- 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



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 6 months


- Not specified


- 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


- Creatinine no greater than 2 mg/dL


- 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


Biologic therapy:

- See Disease Characteristics


- See Disease Characteristics

Endocrine therapy:

- At least 2 weeks since prior systemic corticosteroids


- Not specified


- Not specified


- No concurrent antibiotics for active or resolving infection

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Mark R. Litzow, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

June 2000

Completion Date:

September 2006

Related Keywords:

  • Leukemia
  • recurrent adult acute lymphoblastic leukemia
  • L1 adult acute lymphoblastic leukemia
  • L2 adult acute lymphoblastic leukemia
  • L3 adult acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Stanford University Medical Center Stanford, California  94305-5408
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Ireland Cancer Center Cleveland, Ohio  44106-5065
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Colorado Cancer Research Program, Inc. Denver, Colorado  80209-5031
Veterans Affairs Medical Center - Atlanta (Decatur) Decatur, Georgia  30033
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
New England Medical Center Hospital Boston, Massachusetts  02111
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Hahnemann University Hospital Philadelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
CCOP - Duluth Duluth, Minnesota  55805
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Marshfield Clinic Marshfield, Wisconsin  54449
Medical College of Wisconsin Milwaukee, Wisconsin  53226
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Columbus Columbus, Ohio  43206
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
CCOP - Evanston Evanston, Illinois  60201
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Veterans Affairs Medical Center - Lakeside Chicago Chicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Veterans Affairs Medical Center - New York New York, New York  10010
CCOP - Marshfield Medical Research and Education Foundation Marshfield, Wisconsin  54449
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
CCOP - Oklahoma Tulsa, Oklahoma  74136
Veterans Affairs Medical Center - Pittsburgh Pittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - Miami Miami, Florida  33125
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo Alto Palo Alto, California  94304
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley) Tampa, Florida  33612
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville, Tennessee  37212
Veterans Affairs Medical Center - Gainsville Gainesville, Florida  32608-1197
Veterans Affairs Medical Center - Omaha Omaha, Nebraska  68105