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