Full Text View
Tabular View
No Study Results Posted
Related Studies
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia
This study has been completed.
Study NCT00005786   Information provided by National Cancer Institute (NCI)
First Received: June 2, 2000   Last Updated: July 23, 2008   History of Changes

June 2, 2000
July 23, 2008
September 2000
 
 
 
Complete list of historical versions of study NCT00005786 on ClinicalTrials.gov Archive Site
 
 
 
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia
A Pilot Study of Arsenic Trioxide in the Treatment of Relapsed and Refractory Indolent Lymphomas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor 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 lymphoma or leukemia.

OBJECTIVES:

  • Determine the safety and toxicity profile of arsenic trioxide in patients with relapsed or refractory indolent lymphoma or leukemia.
  • Determine the incidence of complete and partial responses in this patient population when treated with this drug.
  • Evaluate basic science correlates of this drug's activity and mechanism of action in these patients.

OUTLINE: This is a nonrandomized, open-label study.

Patients receive arsenic trioxide IV over 1-4 hours on days 1-5. Treatment repeats every 21 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with responding or stable disease may receive 6 additional courses.

Patients are followed every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 1-1.5 years.

Phase II
Interventional
Treatment, Non-Randomized, Open Label, Active Control
  • Leukemia
  • Lymphoma
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 relapsed or refractory indolent lymphoma or leukemia

    • B-cell chronic lymphocytic leukemia/small lymphocytic lymphoma
    • Prolymphocytic leukemia
    • Hairy cell leukemia
    • Lymphoplasmacytoid lymphoma/immunocytoma
    • Grade I or II follicular lymphoma
    • Nodal marginal zone B-cell lymphoma
    • Extranodal marginal zone B-cell lymphoma (MALT)
    • Splenic marginal zone lymphoma with or without villous lymphocytes
  • Relapsed disease is defined as development of any of the following after a prior response of at least 6 months duration:

    • Lymphadenopathy
    • Splenomegaly
    • Malignant lymphocytosis greater than 5,000/mm^3
    • Infiltration of the bone marrow with malignant lymphocytes
  • Refractory disease

    • No partial response (PR) to prior therapy OR
    • Complete response or PR of less than 6 months duration
  • Must have received at least 1 prior standard cytotoxic drug regimen, including high-dose chemotherapy
  • No known CNS disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • More than 12 weeks

Hematopoietic:

  • See Disease Characteristics
  • Absolute neutrophil count greater than 1,500/mm^3*
  • Platelet count greater than 75,000/mm^3*
  • No thrombocytopenia secondary to active idiopathic thrombocytopenic purpura or anemia secondary to active autoimmune hemolytic anemia NOTE: * Unless cytopenia is due to bone marrow infiltration by lymphoma

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • SGOT/SGPT no greater than 2.5 times upper limit of normal
  • No active viral or autoimmune hepatitis

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No history of cardiac arrhythmia
  • No myocardial infarction within the past 6 months

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal and barrier methods of contraception
  • Sufficient mental capacity to comply with study
  • No active serious infections not controlled by antibiotics
  • No significant peripheral neuropathy of grade 3 or greater regardless of causality
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy:

  • Concurrent glucocorticoids allowed for brief durations

Radiotherapy:

  • Prior radiotherapy to individual sites allowed
  • No prior total body irradiation
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • Recovered from prior therapy
  • Any number of prior therapies allowed
  • 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
 
NCT00005786
 
CDR0000067719, MTS-99-884-ME, NCI-T99-0063
Mount Sinai School of Medicine
National Cancer Institute (NCI)
Study Chair: Luis M. Isola, MD Mount Sinai School of Medicine
National Cancer Institute (NCI)
July 2004

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