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

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005786
First received: June 2, 2000
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
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
Drug: arsenic trioxide
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Arsenic Trioxide in the Treatment of Relapsed and Refractory Indolent Lymphomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Toxicity as assessed by Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria version 2.0 [ Time Frame: Up to 2 years after completion of study treatment ] [ Designated as safety issue: Yes ]
  • Incidence of complete and partial response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Potential surrogate of arsenic trioxide clinical activity [ Time Frame: From baseline to up to 2 years ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: January 2001
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: arsenic trioxide
Given IV
Other Names:
  • Arsenic (III) Oxide
  • Arsenic Sesquioxide
  • Arsenous Acid Anhydride
  • AS2O3
  • Trisenox
Other: laboratory biomarker analysis
Correlative studies

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005786

Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Investigators
Principal Investigator: Luis Isola Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005786     History of Changes
Other Study ID Numbers: NCI-2013-00040, GCO # 99-884 ME*, R01CA085748, CDR0000067719
Study First Received: June 2, 2000
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014