Leukemia Clinical Trial
Official title:
A Phase II Trial of Combination Therapy With Thalidomide, Arsenic Trioxide, Dexamethasone, and Ascorbic Acid (TADA) in Patients With Chronic Idiopathic Myelofibrosis or Overlap Myelodysplastic/Myeloproliferative Disorders
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in
different ways to stop the growth of cancer cells, either by killing the cells or by stopping
them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of
cancer cells. The cancer is said to be resistant to chemotherapy. Giving ascorbic acid may
reduce drug resistance and allow the cancer cells to be killed. Thalidomide may stop the
growth of cancer cells by blocking blood flow to the cancer. Giving arsenic trioxide together
with ascorbic acid, dexamethasone, and thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with
ascorbic acid, dexamethasone, and thalidomide works in treating patients with chronic
idiopathic myelofibrosis or myelodysplastic or myeloproliferative disorders.
OBJECTIVES:
Primary
- Evaluate the efficacy (in terms of response rate) of arsenic trioxide, ascorbic acid,
dexamethasone, and thalidomide in patients with chronic idiopathic myelofibrosis or
myelodysplastic/myeloproliferative disorders.
Secondary
- Determine the rate of disease progression or progression to acute leukemia in patients
treated with this regimen.
- Assess improvement in bone marrow pathology (including degree of fibrosis, percentage of
blasts, and resolution of cytogenetic abnormalities) in patients treated with this
regimen.
- Determine time to response in patients treated with this regimen.
- Determine the reduction of spleen size in patients treated with this regimen.
- Measure clinical responses and quality of life in subgroups treated with this regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive arsenic trioxide IV over 1-2 hours for 5 days and oral ascorbic acid once
daily for 5 days during week 1. Patients then receive arsenic trioxide and ascorbic acid
twice a week in weeks 2-12. Patients also receive oral dexamethasone once daily for 5 days in
weeks 1, 5, 9, and 12 and oral thalidomide once or twice daily in weeks 1-12. Courses repeat
every 12 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and after every course.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
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