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| Sponsor: | Mount Sinai School of Medicine |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005786 |
Purpose
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 refractory lymphoma or leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Drug: arsenic trioxide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Arsenic Trioxide in the Treatment of Relapsed and Refractory Indolent Lymphomas |
| Study Start Date: | September 2000 |
OBJECTIVES:
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of relapsed or refractory indolent lymphoma or leukemia
Relapsed disease is defined as development of any of the following after a prior response of at least 6 months duration:
Refractory disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, New York | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| Study Chair: | Luis M. Isola, MD | Mount Sinai School of Medicine |
More Information
| ClinicalTrials.gov Identifier: | NCT00005786 History of Changes |
| Other Study ID Numbers: | CDR0000067719, MTS-99-884-ME, NCI-T99-0063 |
| Study First Received: | June 2, 2000 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
Waldenstrom macroglobulinemia refractory chronic lymphocytic leukemia refractory hairy cell leukemia recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma prolymphocytic leukemia |
B-cell chronic lymphocytic leukemia recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
|
Leukemia Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Arsenic trioxide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |