Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes
18 Years
N/A
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
Trial Information
Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes
OBJECTIVES:
- Determine the percentage of patients with low-risk myelodysplastic syndromes (MDS) who
achieve a major hematologic improvement after treatment with arsenic trioxide.
- Determine the percentage of patients with high-risk MDS who achieve complete or partial
remission or major hematological improvement after treatment with this drug.
- Determine the durability of responses in patients treated with this drug.
- Determine the duration of overall and progression-free survival of patients treated
with this drug.
- Assess the quality of life of patients treated with this drug.
- Assess the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to risk score (low
risk vs high risk).
Patients receive arsenic trioxide IV 5 days a week on weeks 1-2. Treatment repeats every 4
weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with stable disease or better may receive additional courses of treatment. Patients
who achieve a complete remission (CR) should receive 2 additional courses of treatment after
documentation of CR.
Quality of life is assessed at baseline, every 8 weeks during study, and then at 4 weeks
after study completion.
Patients are followed at 4 weeks, every 3 months until completion of study treatment, and
then annually thereafter.
PROJECTED ACCRUAL: A total of 30-110 patients (15-55 per stratum) will be accrued for this
study.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Scott C. Stromatt, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Cell Therapeutics
Authority:
United States: Federal Government
Study ID:
CDR0000068734
NCT ID:
NCT00020969
Start Date:
March 2001
Completion Date:
Related Keywords:
- Leukemia
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Neoplasms
- refractory anemia
- refractory anemia with ringed sideroblasts
- refractory anemia with excess blasts
- refractory anemia with excess blasts in transformation
- chronic myelomonocytic leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- atypical chronic myeloid leukemia, BCR-ABL1 negative
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- Neoplasms
- Leukemia
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
| Green Cancer Center at Scripps Clinic | La Jolla, California 92037 |
| St. Joseph Hospital Regional Cancer Center - Orange | Orange, California 92868-3849 |
| Lynn Regional Cancer Center West | Boca Raton, Florida 33428 |
| Georgia Cancer Specialists - Northside Office | Atlanta, Georgia 30342 |
| Corpus Christi Cancer Center | Corpus Christi, Texas 78412 |
