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Home > "A" Clinical Trials Conditions > Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia  Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia
For Condition: Waldenstrom's Macroglobulinemia,adult non-Hodgkin's lymphoma,Chronic Lymphocytic Leukemia,Prolymphocytic Leukemia,Hairy Cell Leukemia
Status: Recruiting
Sponsor(s): Mount Sinai Medical Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractorylymphoma or leukemia.
Details: OBJECTIVES: - Determine the safety and toxicity profile of arsenic trioxide in patients with relapsed or refractory indolent lymphoma or leukemia. - Determine the incidence of complete and partial responses in this patient population when treated with this drug. - Evaluate basic science correlates of this drug's activity and mechanism of action in these patients. 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. PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 1-1.5 years.
Eligibility:
Study Type: Interventional,�Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of relapsed or refractory indolent lymphoma or leukemia - B-cell chronic lymphocytic leukemia/small lymphocytic lymphoma - Prolymphocytic leukemia - Hairy cell leukemia - Lymphoplasmacytoid lymphoma/immunocytoma - Grade I or II follicular lymphoma - Nodal marginal zone B-cell lymphoma - Extranodal marginal zone B-cell lymphoma (MALT) - Splenic marginal zone lymphoma with or without villous lymphocytes - Relapsed disease is defined as development of any of the following after a prior response of at least 6 months duration: - Lymphadenopathy - Splenomegaly - Malignant lymphocytosis greater than 5,000/mm^3 - Infiltration of the bone marrow with malignant lymphocytes - Refractory disease - No partial response (PR) to prior therapy OR - Complete response or PR of less than 6 months duration - Must have received at least 1 prior standard cytotoxic drug regimen, including high-dose chemotherapy - No known CNS disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - More than 12 weeks Hematopoietic: - See Disease Characteristics - Absolute neutrophil count greater than 1,500/mm^3* - Platelet count greater than 75,000/mm^3* - No thrombocytopenia secondary to active idiopathic thrombocytopenic purpura or anemia secondary to active autoimmune hemolytic anemia NOTE: * Unless cytopenia is due to bone marrow infiltration by lymphoma Hepatic: - Bilirubin no greater than 2.0 mg/dL - SGOT/SGPT no greater than 2.5 times upper limit of normal - No active viral or autoimmune hepatitis Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No history of cardiac arrhythmia - No myocardial infarction within the past 6 months Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective nonhormonal and barrier methods of contraception - Sufficient mental capacity to comply with study - No active serious infections not controlled by antibiotics - No significant peripheral neuropathy of grade 3 or greater regardless of causality - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - No other concurrent cytotoxic chemotherapy Endocrine therapy: - Concurrent glucocorticoids allowed for brief durations Radiotherapy: - Prior radiotherapy to individual sites allowed - No prior total body irradiation - No concurrent radiotherapy Surgery: - Not specified Other: - Recovered from prior therapy - Any number of prior therapies allowed - No other concurrent investigational agents - No concurrent amphotericin B
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LuisIsola, Study Chair, Mount Sinai Medical Center
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Janice Gabrilove 212-241-6500
Additional Information:
Study ID Numbers: CDR0000067719; NCI-T99-0063,MTS-99-884-ME
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005786
Other Prolymphocytic Leukemia Studies:
1. Genasense™ (Oblimersen Sodium), Fludarabine, and Rituximab in Subjects with Chronic Lymphocytic Leukemia
2. A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies
3. Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia
4. Bortezomib in Treating Patients With Lymphoproliferative Disorders
5. Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer
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Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia
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