Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia

September 25, 2012 updated by: H. Lee Moffitt Cancer Center and Research Institute

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

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

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

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:

  • 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:

  • Eastern Cooperative Oncology Group (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

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
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arsenic Trioxide Treatment
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.
Drug: Arsenic Trioxide
Other Names:
  • Trisenox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Rate of Response (ORR)
Time Frame: 2.5 years
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.
2.5 years

Collaborators and Investigators

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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Thomas P. Loughran, MD, H. Lee Moffitt Cancer Center and Research Institute

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

August 1, 2000

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 26, 2012

Last Update Submitted That Met QC Criteria

September 25, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-12395
  • NCI-1230 (Other Identifier: NCI)

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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