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

January 31, 2013 updated by: National Cancer Institute (NCI)

A Pilot Study of Arsenic Trioxide in the Treatment of Relapsed and Refractory Indolent Lymphomas

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (arsenic trioxide)
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.
Other: laboratory biomarker analysis
Correlative studies
Drug: arsenic trioxide
Given IV
Other Names:
  • Arsenic (III) Oxide
  • Arsenic Sesquioxide
  • Arsenous Acid Anhydride
  • AS2O3
  • Trisenox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 2 years after completion of study treatment
Incidence of complete and partial response
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Potential surrogate of arsenic trioxide clinical activity
Time Frame: From baseline to up to 2 years
From baseline to up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Luis Isola, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

June 2, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

February 1, 2013

Last Update Submitted That Met QC Criteria

January 31, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2013-00040
  • GCO # 99-884 ME*
  • R01CA085748 (U.S. NIH Grant/Contract)
  • CDR0000067719 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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