Thalidomide in Treating Patients With Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Chronic Myelomonocytic Leukemia
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- North Central Cancer Treatment Group
Arms of the Study
Arm 1
Experimental
Treatment (thalidomide)
Patients receive oral thalidomide once daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity.