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

Recurrent Small Lymphocytic Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00005786
• Other study ID #: NCI-2013-00040
• Secondary ID: GCO # 99-884 ME*
• Status: Terminated
• Phase: N/A
• First received: June 2, 2000
• Last updated: January 31, 2013
• Start date: January 2001

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Prolymphocytic
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• 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
• Waldenstrom Macroglobulinemia
• Waldenström Macroglobulinemia

Intervention

Drug:
• arsenic trioxide
Given IV

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity as assessed by Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria version 2.0		Up to 2 years after completion of study treatment	Yes
Primary	Incidence of complete and partial response		Up to 2 years	No
Secondary	Potential surrogate of arsenic trioxide clinical activity		From baseline to up to 2 years	No