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Home > "A" Clinical Trials Conditions > Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

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



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

For Condition: recurrent adult acute lymphoblastic leukemia,L3 adult acute lymphoblastic leukemia,L1 adult acute lymphoblastic leukemia,L2 adult acute lymphoblastic leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: 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.
Details: OBJECTIVES: I. Determine the complete remission rate of patients with relapsed or refractory acute lymphoblastic leukemia treated with arsenic trioxide. II. Determine the toxic effects of induction arsenic trioxide in this patient population. PROTOCOL 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MarkLitzow,  Study Chair,  Eastern Cooperative Oncology Group

CCOP - Kalamazoo
Kalamazoo,  Michigan,  49007-3731
United States
 

Albert Einstein Comprehensive Cancer Center
Bronx,  New York,  10461
United States
 

Veterans Affairs Medical Center - Miami
Miami,  Florida,  33125
United States
 

Veterans Affairs Medical Center - New York
New York City,  New York,  10010
United States
 

Emory University Hospital - Atlanta
Atlanta,  Georgia,  30322
United States
 

Medical College of Wisconsin
Milwaukee,  Wisconsin,  53226
United States
 

CCOP - Illinois Oncology Research Association
Peoria,  Illinois,  61602
United States
 

Beth Israel Deaconess Medical Center
Boston,  Massachusetts,  02215
United States
 

Veterans Affairs Medical Center - Lakeside Chicago
Chicago,  Illinois,  60611
United States
 

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

Veterans Affairs Medical Center - Brooklyn
Brooklyn,  New York,  11209
United States
 

CCOP - Cedar Rapids Oncology Project
Cedar Rapids,  Iowa,  52403-1206
United States
 

Veterans Affairs Medical Center - Palo Alto
Palo Alto,  California,  94304
United States
 

CCOP - Missouri Valley Cancer Consortium
Omaha,  Nebraska,  68131
United States
 

MBCCOP - San Juan
San Juan,  ,  00927-5800
Puerto Rico
 

CCOP - Columbus
Columbus,  Ohio,  43206
United States
 

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

CCOP - Christiana Care Health Services
Wilmington,  Delaware,  19899
United States
 

CCOP - Merit Care Hospital
Fargo,  North Dakota,  58122
United States
 

Veterans Affairs Medical Center - Tampa (Haley)
Tampa,  Florida,  33612
United States
 

CCOP - Colorado Cancer Research Program, Inc.
Denver,  Colorado,  80209-5031
United States
 

CCOP - Iowa Oncology Research Association
Des Moines,  Iowa,  50309-1016
United States
 

CCOP - Carle Cancer Center
Urbana,  Illinois,  61801
United States
 

CCOP - Geisinger Clinic and Medical Center
Danville,  Pennsylvania,  17822-2001
United States
 

Veterans Affairs Medical Center - Gainsville
Gainesville,  Florida,  32608-1197
United States
 

New England Medical Center Hospital
Boston,  Massachusetts,  02111
United States
 

CCOP - Evanston
Evanston,  Illinois,  60201
United States
 

Veterans Affairs Medical Center - Omaha
Omaha,  Nebraska,  68105
United States
 

Marshfield Clinic
Marshfield,  Wisconsin,  54449
United States
 

University of Pennsylvania Cancer Center
Philadelphia,  Pennsylvania,  19104-4283
United States
 

CCOP - Marshfield Medical Research and Education Foundation
Marshfield,  Wisconsin,  54449
United States
 

Veterans Affairs Medical Center - Minneapolis
Minneapolis,  Minnesota,  55417
United States
 

Veterans Affairs Medical Center - Pittsburgh
Pittsburgh,  Pennsylvania,  15240
United States
 

CCOP - Ochsner
New Orleans,  Louisiana,  70121
United States
 

CCOP - Oklahoma
Tulsa,  Oklahoma,  74136
United States
 

University of Minnesota Cancer Center
Minneapolis,  Minnesota,  55455
United States
 

NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City,  New York,  10016
United States
 

Hahnemann University Hospital
Philadelphia,  Pennsylvania,  19102-1192
United States
 

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago,  Illinois,  60611-3013
United States
 

CCOP - Metro-Minnesota
St. Louis Park,  Minnesota,  55416
United States
 

Ireland Cancer Center
Cleveland,  Ohio,  44106-5065
United States
 

University of Wisconsin Comprehensive Cancer Center
Madison,  Wisconsin,  53792-6164
United States
 

University of Pittsburgh Cancer Institute
Pittsburgh,  Pennsylvania,  15213-3489
United States
 

Veterans Affairs Medical Center - Madison
Madison,  Wisconsin,  53705
United States
 

Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee,  Wisconsin,  53295
United States
 

Holden Comprehensive Cancer Center at The University of Iowa
Iowa City,  Iowa,  52242-1009
United States
 

Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur,  Georgia,  30033
United States
 

Fox Chase Cancer Center
Philadelphia,  Pennsylvania,  19111
United States
 

Stanford University Medical Center
Stanford,  California,  94305-5408
United States
 

Indiana University Cancer Center
Indianapolis,  Indiana,  46202-5289
United States
 

Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis,  Indiana,  46202
United States
 

CCOP - Southern Nevada Cancer Research Foundation
Las Vegas,  Nevada,  89106
United States
 

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia,  Pennsylvania,  19107-5541
United States
 

CCOP - Northern New Jersey
Hackensack,  New Jersey,  07601
United States
 

Veterans Affairs Medical Center - East Orange
East Orange,  New Jersey,  07018-1095
United States
 

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

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

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

Vanderbilt-Ingram Cancer Center
Nashville,  Tennessee,  37232-6838
United States
 

CCOP - Sioux Community Cancer Consortium
Sioux Falls,  South Dakota,  57104
United States
 

Veterans Affairs Medical Center - San Juan
San Juan,  ,  00927-5800
Puerto Rico
 

H. Lee Moffitt Cancer Center and Research Institute
Tampa,  Florida,  33612-9497
United States
 

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville,  Tennessee,  37212
United States
 

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore,  Maryland,  21231-2410
United States
 

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

CCOP - Duluth
Duluth,  Minnesota,  55805
United States
 

Mayo Clinic Cancer Center
Rochester,  Minnesota,  55905
United States
 

CCOP - MainLine Health
Wynnewood,  Pennsylvania,  19096
United States
 

Cancer Institute of New Jersey
New Brunswick,  New Jersey,  08901
United States
 

Pretoria Academic Hospitals
Pretoria,  ,  0001
South Africa
 

CCOP - Scottsdale Oncology Program
Scottsdale,  Arizona,  85259-5404
United States
 


Additional Information:
Study ID Numbers:
  CDR0000068016;  E-9998
Study Start Date: June 2000
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006008

Other L1 Adult Acute Lymphoblastic Leukemia Studies:
1. 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies

2. 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia

3. Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia

4. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

5. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia

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

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