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TerminatedNCT00006092Updated Sep 26, 2012

Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia

A Phase 2 interventional study of Arsenic Trioxide in Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-26.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, Interventional, and Treatment

Why this study was terminated
low accrual
Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Leukemia

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Keywords

  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • chronic myelogenous leukemia, BCR-ABL1 positive
  • lymphoid leukemia
  • myeloid and monocytic leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 2 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • 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

Interventions

  • DrugArsenic Trioxide

    Also known as: Trisenox

06

What researchers measure

Primary outcomes

  1. Objective Rate of Response (ORR)

    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.

    Time frame: 2.5 years

07

Study locations

1 site
  • H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612-9497, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00006092
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Aug 2000
Primary completion
Mar 2003
Completion
Mar 2003
Last update
Sep 26, 2012

Study contacts

Thomas P. Loughran, MD
study chair · H. Lee Moffitt Cancer Center and Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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