Status:
TERMINATED
Azacitidine and Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia
Lead Sponsor:
Medical University of South Carolina
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as azacitidine and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividin...
Detailed Description
OBJECTIVES: Primary * Determine the response rate in patients with myelodysplastic syndromes or chronic myelomonocytic leukemia treated with azacitidine and arsenic trioxide. Secondary * Determine...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of myelodysplastic syndrome or chronic myelomonocytic leukemia
- International Prognostic Scoring System (IPSS) score ≥ intermediate-1
- Low IPSS score allowed provided patient meets ≥ 1 of the following criteria:
- Platelet count ≤ 50,000/mm\^3
- Required platelet or packed red cell transfusions within the past 4 weeks
- Neutropenic (i.e., absolute neutrophil count \< 1,000/mm\^3) AND has infections requiring antibiotic treatment
- No prior leukemia or refractory anemia with excess blasts in transformation
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- More than 12 weeks
- Hematopoietic
- See Disease Characteristics
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Renal
- Creatinine ≤ 1.5 times ULN
- Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Baseline QTc \< 500 msec
- QTc interval \< 460 msec with potassium \> 4.0 mEq/L and magnesium \> 1.8 mg/L
- Immunologic
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs
- No ongoing or active infection
- HIV negative
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- No other malignancy within the past 12 months
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 4 weeks since prior administration of any of the following:
- Interferon
- Filgrastim (G-CSF), sargramostim (GM-CSF), epoetin alfa, or other hematopoietic cytokines
- Thalidomide or thalidomide analogs
- No concurrent epoetin alfa
- Chemotherapy
- More than 4 weeks since prior chemotherapy
- No prior arsenic trioxide or azacitidine
- No other concurrent chemotherapy
- Endocrine therapy
- More than 4 weeks since prior steroids
- No concurrent androgenic steroids
- Concurrent steroids for adrenal failure or as prophylaxis for nausea allowed
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- More than 4 weeks since prior retinoids
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2006
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00118196
Start Date
April 1 2005
End Date
August 11 2006
Last Update
May 11 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425