Overview
Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
Status:
Terminated
Terminated
Trial end date:
2005-01-01
2005-01-01
Target enrollment:
0
0
Participant gender:
All
All
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 myelodysplastic syndromes.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
CTI BioPharmaCollaborator:
National Cancer Institute (NCI)Treatments:
Arsenic Trioxide
Criteria
DISEASE CHARACTERISTICS:- Diagnosis of myelodysplastic syndromes (MDS)
- Refractory anemia (RA)
- RA with ringed sideroblasts
- RA with excess blasts (RAEB)
- RAEB in transformation
- Chronic myelomonocytic leukemia
- Low-risk MDS patients:
- If serum erythropoietin less than 200 IU/mL, must have failed prior recombinant
epoetin alfa (EPO) trial
- No prior acute myeloid leukemia
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- More than 3 months
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 2.5 times upper limit of normal (ULN)
- SGPT and SGOT no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- Absolute QT interval less than 460 msec in the presence of magnesium greater than 1.8
mg/dL and potassium greater than 4.0 mEq/L
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 30 days since prior biologic therapy (except recombinant EPO in low-risk MDS
patients)
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 30 days since prior radiotherapy
Surgery:
- Not specified
Other:
- At least 30 days since prior cytotoxic agents
- At least 30 days since prior investigational agents
- No prior arsenic trioxide