Trials / Unknown
UnknownNCT00003885
Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Leukemia, Chronic Myeloide Leukemia, Myelodysplasia, Lymphoma, or Myeloma
Phase II Study of Arsenic Trioxide in Relapsed/Refractory Acute Leukemia and Blast Crisis of Chronic Myeloid Leukemia
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Our Lady of Mercy Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer 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 recurrent or refractory acute leukemia, chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma.
Detailed description
OBJECTIVES: I. Determine the effect of arsenic trioxide on the remission rate in patients with recurrent or refractory acute leukemia, blast crisis chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma. II. Determine the time to progression and survival in patients treated with this regimen. III. Determine the toxic effects of this regimen in these patients. OUTLINE: Patients are stratified into 1 of 8 categories: first relapse no greater than 6 months after complete response vs second relapse or refractory vs prior hematologic disorder vs myeloid blast crisis of chronic myeloid leukemia vs lymphoid leukemia vs lymphoma vs myeloma vs myelodysplasia. Patients receive IV arsenic trioxide over 2-3 hours for 5 consecutive days with 2 days of rest. Treatment continues in the absence of disease progression until complete response or 90 days is reached. Upon achieving complete response, treatment is discontinued for 30 days. Patients exhibiting complete response receive a second 28 day course of consolidation therapy while in remission starting no sooner than 31 days after the end of induction therapy. Patients are followed monthly. PROJECTED ACCRUAL: A total of 14-29 patients per lymphoma and myeloma stratum and a total of 31 patients per leukemia stratum will be accrued for this study within 18-24 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | arsenic trioxide |
Timeline
- Start date
- 1997-11-01
- First posted
- 2004-08-18
- Last updated
- 2013-11-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00003885. Inclusion in this directory is not an endorsement.