Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	MTS-99-884-ME NCI-T99-0063, NCT00005786, T99-0063

Objectives

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

Entry 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/mm³
  • 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

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

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/mm³*
• Platelet count greater than 75,000/mm³*
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Mount Sinai Medical Center

Luis Isola, MD, Protocol chair		Ph: 212-241-6021 Email: Luis.Isola@msnyuhealth.org

Registry Information
Official Title		A Pilot Study of Arsenic Trioxide in the Treatment of Relapsed and Refractory Indolent Lymphomas
Trial Start Date		2000-09-21
Registered in ClinicalTrials.gov		NCT00005786
Date Submitted to PDQ		2000-03-02
Information Last Verified		2004-07-26

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