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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.
Study NCT00006092   Information provided by National Cancer Institute (NCI)
First Received: August 3, 2000   Last Updated: July 23, 2008   History of Changes

August 3, 2000
July 23, 2008
October 2000
 
 
 
Complete list of historical versions of study NCT00006092 on ClinicalTrials.gov Archive Site
 
 
 
Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia
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

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.

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.

Phase II
Interventional
Treatment
Leukemia
Drug: arsenic trioxide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006092
 
CDR0000068097, MCC-12395, NCI-1230
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Study Chair: Thomas P. Loughran, MD H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP