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


N/A
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity as assessed by Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria version 2.0

Outcome Time Frame:

Up to 2 years after completion of study treatment

Safety Issue:

Yes

Principal Investigator

Luis Isola

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2013-00040

NCT ID:

NCT00005786

Start Date:

January 2001

Completion Date:

Related Keywords:

  • 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
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Prolymphocytic
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone

Name

Location

Mount Sinai Medical CenterNew York, New York  10029