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

Primary Purpose

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Prolymphocytic Leukemia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
arsenic trioxide
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have a diagnosis of relapsed or refractory low-grade lymphoma Patients must have disease that has relapsed from or is refractory to standard cytotoxic therapy; patients must have received at least one standard cytotoxic drug regimen; there is no limit on the number of prior therapies, including high dose chemotherapy regimens, provided the patient has recovered from prior toxicities; relapsed disease is defined as the development of lymphadenopathy, splenomegaly, malignant lymphocytosis greater than 5,000, or infiltration of the bone marrow with malignant lymphocytes in a patient who had previously achieved a response of at least six months in duration; refractory disease is defined as never achieving a PR or a CR or PR that is less than six months in duration; prior total body irradiation is not allowed; radiation to individual site is permitted, and is not included as a regimen Serum creatinine =< 2.0 mg/dl Total bilirubin =< 2.0 mg/dl Serum SGOT, SGPT =< 2.5 times the upper limit of institutional normal Patients who are female and have childbearing potential must have a negative pregnancy test; all patients who are engaging in sexual intercourse that may result in a pregnancy must use appropriate contraception while receiving treatment on this protocol Patients must have sufficient mental capacity to understand the explanation of the study and to give his or her informed signed consent Patients must display Karnofsky performance status of 60% or greater Patients should have a life expectancy of > 12 weeks so as to permit adequate follow-up of toxicity Patients must have recovered from the toxicity of recent therapy prior to enrollment in this study Absolute neutrophil count > 1500/uL, unless cytopenias are the result of bone marrow infiltration by lymphoma; permission of the protocol PI is required in this situation Platelet count > 75,000/uL, unless cytopenias are the result of bone marrow infiltration by lymphoma; permission of the protocol PI is required in this situation; patients with thrombocytopenia secondary to active ITP or anemia secondary to an active autoimmune hemolytic anemia at the time of evaluation are excluded Exclusion Criteria: Pregnant or lactating women; arsenic compounds could be transferred to the fetus or child with resultant harm Concurrent treatment with cytotoxic chemotherapy, radiation or investigational agents; this exclusion does not include concurrent glucocorticoids fro brief durations; patients must have recovered from the toxicity of prior therapy prior to enrollment in this study Active serious infections not controlled by antibiotics Inability to comply with the treatment protocol or follow-up testing Patients with HIV infection; there are currently insufficient data to support the safety of administering arsenic compounds in combination with anti-retroviral drugs Patients with active viral or autoimmune hepatitis Patients with history of cardiac arrhythmia, heart block, or myocardial infarction within the past 6 months Patients with known CNS disease Patients requiring amphotericin B therapy Patients with significant peripheral neuropathy (>= grade 3), regardless of cause

Sites / Locations

  • Mount Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (arsenic trioxide)

Arm Description

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.

Outcomes

Primary Outcome Measures

Toxicity as assessed by Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria version 2.0
Incidence of complete and partial response

Secondary Outcome Measures

Potential surrogate of arsenic trioxide clinical activity

Full Information

First Posted
June 2, 2000
Last Updated
January 31, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005786
Brief Title
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia
Official Title
A Pilot Study of Arsenic Trioxide in the Treatment of Relapsed and Refractory Indolent Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
January 2001 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory lymphoma or leukemia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the safety and toxicity profile of arsenic trioxide in patients with relapsed or refractory low-grade lymphomas. II. To determine the incidence of complete and partial responses to arsenic trioxide in patients with previously treated low-grade lymphomas. III. To evaluate basic science correlates of arsenic trioxide activity in order to improve our understanding of the mechanism of action for arsenic trioxide in patients with low-grade lymphomas. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Prolymphocytic Leukemia, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (arsenic trioxide)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
arsenic trioxide
Other Intervention Name(s)
Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid Anhydride, AS2O3, Trisenox
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Toxicity as assessed by Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria version 2.0
Time Frame
Up to 2 years after completion of study treatment
Title
Incidence of complete and partial response
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Potential surrogate of arsenic trioxide clinical activity
Time Frame
From baseline to up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have a diagnosis of relapsed or refractory low-grade lymphoma Patients must have disease that has relapsed from or is refractory to standard cytotoxic therapy; patients must have received at least one standard cytotoxic drug regimen; there is no limit on the number of prior therapies, including high dose chemotherapy regimens, provided the patient has recovered from prior toxicities; relapsed disease is defined as the development of lymphadenopathy, splenomegaly, malignant lymphocytosis greater than 5,000, or infiltration of the bone marrow with malignant lymphocytes in a patient who had previously achieved a response of at least six months in duration; refractory disease is defined as never achieving a PR or a CR or PR that is less than six months in duration; prior total body irradiation is not allowed; radiation to individual site is permitted, and is not included as a regimen Serum creatinine =< 2.0 mg/dl Total bilirubin =< 2.0 mg/dl Serum SGOT, SGPT =< 2.5 times the upper limit of institutional normal Patients who are female and have childbearing potential must have a negative pregnancy test; all patients who are engaging in sexual intercourse that may result in a pregnancy must use appropriate contraception while receiving treatment on this protocol Patients must have sufficient mental capacity to understand the explanation of the study and to give his or her informed signed consent Patients must display Karnofsky performance status of 60% or greater Patients should have a life expectancy of > 12 weeks so as to permit adequate follow-up of toxicity Patients must have recovered from the toxicity of recent therapy prior to enrollment in this study Absolute neutrophil count > 1500/uL, unless cytopenias are the result of bone marrow infiltration by lymphoma; permission of the protocol PI is required in this situation Platelet count > 75,000/uL, unless cytopenias are the result of bone marrow infiltration by lymphoma; permission of the protocol PI is required in this situation; patients with thrombocytopenia secondary to active ITP or anemia secondary to an active autoimmune hemolytic anemia at the time of evaluation are excluded Exclusion Criteria: Pregnant or lactating women; arsenic compounds could be transferred to the fetus or child with resultant harm Concurrent treatment with cytotoxic chemotherapy, radiation or investigational agents; this exclusion does not include concurrent glucocorticoids fro brief durations; patients must have recovered from the toxicity of prior therapy prior to enrollment in this study Active serious infections not controlled by antibiotics Inability to comply with the treatment protocol or follow-up testing Patients with HIV infection; there are currently insufficient data to support the safety of administering arsenic compounds in combination with anti-retroviral drugs Patients with active viral or autoimmune hepatitis Patients with history of cardiac arrhythmia, heart block, or myocardial infarction within the past 6 months Patients with known CNS disease Patients requiring amphotericin B therapy Patients with significant peripheral neuropathy (>= grade 3), regardless of cause
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Isola
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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

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