Study Stopped
Administratively complete.
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia
A Pilot Study of Arsenic Trioxide in the Treatment of Relapsed and Refractory Indolent Lymphomas
4 other identifiers
interventional
25
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2000
CompletedStudy Start
First participant enrolled
January 1, 2001
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedFebruary 1, 2013
January 1, 2013
3.8 years
June 2, 2000
January 31, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Toxicity as assessed by Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria version 2.0
Up to 2 years after completion of study treatment
Incidence of complete and partial response
Up to 2 years
Secondary Outcomes (1)
Potential surrogate of arsenic trioxide clinical activity
From baseline to up to 2 years
Study Arms (1)
Treatment (arsenic trioxide)
EXPERIMENTALPatients 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.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or lactating women; arsenic compounds could be transferred to the fetus or child with resultant harm
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Medical Center
New York, New York, 10029, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis Isola
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2000
First Posted
January 27, 2003
Study Start
January 1, 2001
Primary Completion
November 1, 2004
Last Updated
February 1, 2013
Record last verified: 2013-01