Thalidomide in Treating Patients With Myelodysplastic Syndrome
Completed · Phase 2
Conditions studied: Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Refractory Anemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Excess Blasts in Transformation, Refractory Anemia With Ringed Sideroblasts, Secondary Myelodysplastic Syndromes
In brief
Phase II trial to study the effectiveness of thalidomide in treating patients who have myelodysplastic syndrome. Thalidomide may improve the immune system's ability to fight myelodysplastic syndrome
Key facts
- Study ID
- NCT00015990
- Run by
- National Cancer Institute (NCI)
- People needed
- 29
- Starts
- 2001-04-01
- Last updated by the study team
- 2013-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pre-transfusion hemoglobin =< 10 g/dL
- Pre-transfusion platelet count =< 50,000/μL
- Absolute neutrophil count < 1000/μL
- Total bilirubin ≤ 1.5 x UNL
- Alkaline phosphatase ≤ 3 x UNL
- AST ≤ 3 x UNL
- Creatinine ≤ 1.5 x UNL
- A diagnosis of MDS as demonstrated in the bone marrow; any subtypes are eligible including:
- Refractory anemia (cytopenia)
- Refractory anemia with ringed sideroblasts
- Chronic myelomonocytic leukemia
- Refractory anemia with excess blasts
- Refractory anemia with excess blasts in transformation
- Unclassified MDS
- Patients with refractory anemia with excess blasts in transformation who are not candidates for (or who decline) induction chemotherapy are eligible; those patients who were candidates for (and accepted) induction chemotherapy should have failed at least 1 chemotherapy regimen prior to entry
- Patients who are candidates for marrow transplantation should have this option discussed prior to study entry
You may not qualify if…
- Any of the following as this regimen may be harmful to a developing fetus or nursing child:
- Pregnant women
- Nursing women
- Women of childbearing potential or their sexual partners who are unwilling to employ 2 adequate methods of contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
- Peripheral neuropathy (by history or clinical exam)
- Concomitant therapy ≤ 30 days for myelodysplastic syndrome with any specific agent including chemotherapy, corticosteroids and/or growth factors (i.e. erythropoietin, G-CSF, GM-CSF, thrombopoietic agent); patients on chronic low-dose corticosteriods (< 20 mg/d) for reasons other than MDS are allowed
- Uncontrolled infections
Where it is running
- North Central Cancer Treatment Group — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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