Trials / Terminated
TerminatedNCT00005786
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
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | arsenic trioxide | Given IV |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2001-01-01
- Primary completion
- 2004-11-01
- First posted
- 2003-01-27
- Last updated
- 2013-02-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00005786. Inclusion in this directory is not an endorsement.