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Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia
This study has been completed.

First Received on June 2, 2000.   Last Updated on July 23, 2008   History of Changes
Sponsor: Mount Sinai School of Medicine
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005786
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Drug: arsenic trioxide
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Arsenic Trioxide in the Treatment of Relapsed and Refractory Indolent Lymphomas

Resource links provided by NLM:


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

Study Start Date: September 2000
Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005786

Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Study Chair: Luis M. Isola, MD Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005786     History of Changes
Other Study ID Numbers: CDR0000067719, MTS-99-884-ME, NCI-T99-0063
Study First Received: June 2, 2000
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Waldenstrom macroglobulinemia
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
prolymphocytic leukemia
B-cell chronic lymphocytic leukemia
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Additional relevant MeSH terms:
Leukemia
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012