Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia
NCT ID: NCT00005786
Last Updated: 2013-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
25 participants
INTERVENTIONAL
2001-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Non- Hodgkin's Lymphoma
NCT00005040
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Hodgkin's Disease
NCT00005595
Study of Akt Inhibitor MK2206 in Patients With Relapsed Lymphoma
NCT01258998
A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma
NCT04362007
506U78 in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or T-cell Lymphoma
NCT00005950
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
arsenic trioxide
Given IV
laboratory biomarker analysis
Correlative studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
arsenic trioxide
Given IV
laboratory biomarker analysis
Correlative studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Luis Isola
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mount Sinai Medical Center
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GCO # 99-884 ME*
Identifier Type: -
Identifier Source: secondary_id
CDR0000067719
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2013-00040
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.