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

June 20, 2013 updated by: Eastern Cooperative Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927-5800
        • MBCCOP - San Juan
      • San Juan, Puerto Rico, 00927-5800
        • Veterans Affairs Medical Center - San Juan
  • South Africa
      • Pretoria, South Africa, 0001
        • Pretoria Academic Hospitals
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5404
        • CCOP - Scottsdale Oncology Program
    • California
      • Duarte, California, United States, 91010-3000
        • Cancer Center and Beckman Research Institute, City of Hope
      • Palo Alto, California, United States, 94304
        • Veterans Affairs Medical Center - Palo Alto
      • Stanford, California, United States, 94305-5408
        • Stanford University Medical Center
    • Colorado
      • Denver, Colorado, United States, 80209-5031
        • CCOP - Colorado Cancer Research Program, Inc.
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • CCOP - Christiana Care Health Services
    • Florida
      • Gainesville, Florida, United States, 32608-1197
        • Veterans Affairs Medical Center - Gainsville
      • Miami, Florida, United States, 33125
        • Veterans Affairs Medical Center - Miami
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
      • Tampa, Florida, United States, 33612
        • Veterans Affairs Medical Center - Tampa (Haley)
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital - Atlanta
      • Decatur, Georgia, United States, 30033
        • Veterans Affairs Medical Center - Atlanta (Decatur)
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
      • Chicago, Illinois, United States, 60611
        • Veterans Affairs Medical Center - Lakeside Chicago
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
      • Evanston, Illinois, United States, 60201
        • CCOP - Evanston
      • Peoria, Illinois, United States, 61602
        • CCOP - Illinois Oncology Research Association
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Veterans Affairs Medical Center - Indianapolis (Roudebush)
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines, Iowa, United States, 50309-1016
        • CCOP - Iowa Oncology Research Association
      • Iowa City, Iowa, United States, 52242-1009
        • Holden Comprehensive Cancer Center at the University of Iowa
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • CCOP - Ochsner
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney kimmel comprehensive cancer center at johns hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02111
        • New England Medical Center Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Ann Arbor Regional
      • Kalamazoo, Michigan, United States, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
      • Minneapolis, Minnesota, United States, 55417
        • Veterans Affairs Medical Center - Minneapolis
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, United States, 68105
        • Veterans Affairs Medical Center - Omaha
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New Jersey
      • East Orange, New Jersey, United States, 07018-1095
        • Veterans Affairs Medical Center - East Orange
      • Hackensack, New Jersey, United States, 07601
        • CCOP - Northern New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Cancer Institute of New Jersey
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Comprehensive Cancer Center
      • Brooklyn, New York, United States, 11209
        • Veterans Affairs Medical Center - Brooklyn
      • New York, New York, United States, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center
      • New York, New York, United States, 10010
        • Veterans Affairs Medical Center - New York
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • CCOP - Merit Care Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
      • Columbus, Ohio, United States, 43206
        • CCOP - Columbus
      • Toledo, Ohio, United States, 43623-3456
        • CCOP - Toledo Community Hospital Oncology Program
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • CCOP - Oklahoma
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19102-1192
        • Hahnemann University Hospital
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • University of Pennsylvania Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107-5541
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15213-3489
        • University of Pittsburgh Cancer Institute
      • Pittsburgh, Pennsylvania, United States, 15240
        • Veterans Affairs Medical Center - Pittsburgh
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - MainLine Health
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • CCOP - Sioux Community Cancer Consortium
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37212
        • Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center
      • Madison, Wisconsin, United States, 53705
        • Veterans Affairs Medical Center - Madison
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Marshfield, Wisconsin, United States, 54449
        • CCOP - Marshfield Medical Research and Education Foundation
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53295
        • Veterans Affairs Medical Center - Milwaukee (Zablocki)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

November 4, 2003

First Posted (Estimate)

November 5, 2003

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

August 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068016
  • E-9998

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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