Thalidomide in Treating Patients With Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Thalidomide

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