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Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia
This study has been completed.
First Received: August 3, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006092
  Purpose

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 recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia.


Condition Intervention Phase
Leukemia
Drug: arsenic trioxide
Phase II

MedlinePlus related topics: Arsenic Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Arsenic trioxide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Arsenic Trioxide for Induction Therapy of Adult Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia and Previously Untreated Chronic Myeloid Leukemia With Blast Crisis

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2000
Detailed Description:

OBJECTIVES:

  • Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide.
  • Determine the duration of hematologic response and overall survival of these patients when treated with this regimen.
  • Determine the pattern of clinical adverse experience in these patients when treated with this regimen.
  • Determine the pharmacokinetic profile of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course.

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

PROJECTED ACCRUAL: A total of 24-49 patients will be accrued for this study within 2.5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of one of the following:

    • Acute lymphoblastic leukemia

      • Philadelphia chromosome (Bcr-abl) positive
      • Refractory to initial therapy OR recurrent following 1 induction therapy regimen with or without consolidation therapy and/or bone marrow transplantation
    • Blastic phase chronic myelogenous leukemia

      • Philadelphia chromosome (Bcr-abl) positive
      • Previously untreated OR recurrent or refractory following 1 induction therapy regimen with or without consolidation therapy including imatinib mesylate
  • Must not be eligible for bone marrow transplant

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 2.0 times upper limit of normal (ULN)
  • AST/ALT no greater than 2 times ULN

Renal:

  • Creatinine no greater than 2.0 times ULN
  • Creatinine clearance greater than 70 mL/min

Cardiovascular:

  • No uncontrolled angina
  • No New York Heart Association class III or IV heart disease
  • No second degree heart block without pacemaker

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study
  • HIV negative
  • No uncontrolled infection or other serious concurrent illness
  • No peripheral neuropathy
  • No potassium less than 3.0 or greater than 5.5 mEq/L that can not be corrected OR
  • No magnesium less than 1.2 or greater than 2.5 mEq/L that can not be corrected
  • Electrolyte imbalances must be corrected prior to study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics
  • At least 28 days since prior chemotherapy
  • At least 24 hours since prior hydroxyurea
  • No prior arsenic trioxide
  • No other concurrent cytotoxic chemotherapy except intrathecal chemotherapy for CNS leukemia

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 28 days since prior radiotherapy
  • No concurrent radiotherapy including for palliation

Surgery:

  • Not specified

Other:

  • At least 14 days since prior imatinib mesylate
  • No other concurrent investigational agents
  • No concurrent amphotericin B
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006092

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Study Chair: Thomas P. Loughran, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068097, MCC-12395, NCI-1230
Study First Received: August 3, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006092     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia

Study placed in the following topic categories:
Philadelphia Chromosome
Blast Crisis
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Myeloproliferative Disorders
Arsenic trioxide
Leukemia, Myeloid
Recurrence
Leukemia
Lymphatic Diseases
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chromosome Aberrations
Chronic Myelogenous Leukemia
Bone Marrow Diseases
Lymphoproliferative Disorders
Lymphoma
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:
Philadelphia Chromosome
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Hematologic Diseases
Myeloproliferative Disorders
Arsenic trioxide
Leukemia, Myeloid
Pharmacologic Actions
Translocation, Genetic
Leukemia
Lymphatic Diseases
Neoplasms
Pathologic Processes
Therapeutic Uses
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chromosome Aberrations
Bone Marrow Diseases
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 06, 2009