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Thalidomide in Treating Patients With Myelodysplastic Syndrome

This study has been completed.
Study NCT00015990.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Thalidomide in Treating Patients With Myelodysplastic Syndrome
Official Title  Phase II Study of Thalidomide in the Treatment of Myelodysplastic Syndromes in Adults: A Clinical and Biologic Study
Brief Summary

RATIONALE: Thalidomide may improve the immune system's ability to fight myelodysplastic syndrome.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have myelodysplastic syndrome.

Detailed Description

OBJECTIVES: I. Determine whether thalidomide improves cytopenias in patients with myelodysplastic syndromes. II. Determine the toxicity of this regimen in these patients. III. Determine whether this regimen down regulates the peripheral blood levels of tumor necrosis factor alpha, interferon gamma, and interleukin-12 and whether these changes correlate with clinical response in these patients. IV. Determine whether this regimen alters the peripheral blood T-cell subset distribution and whether these changes correlate with clinical response in these patients. V. Determine the effect of this regimen on bone marrow microvessel density and whether these effects correlate with clinical response in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prognosis (favorable vs unfavorable). (Favorable stratum closed to accrual 12/28/01) Patients receive oral thalidomide once daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 1 year and then annually for 4 years.

PROJECTED ACCRUAL: A total of 20-58 patients (10-29 per stratum) will be accrued for this study within 20 months. (Favorable stratum closed to accrual 12/28/01)

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Leukemia
Myelodysplastic Syndromes
Intervention  Drug: thalidomide
MEDLINE PMIDs 16826578
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  April 2001
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS: Diagnosis of myelodysplastic syndromes (MDS) in the bone marrow, including any of the following subtypes: Refractory anemia (RA) (cytopenia) RA with ringed sideroblasts Chronic myelomonocytic leukemia RA with excess blasts (RAEB) RAEB in transformation Unclassified MDS Must have one of the following: Pretransfusion hemoglobin no greater than 10 g/dL Pretransfusion platelet count no greater than 50,000/mm3 Absolute neutrophil count less than 1,000/mm3 Patients who are ineligible for or refuse induction chemotherapy for RAEB in transformation are allowed (If candidate for and accept induction chemotherapy, must have failed at least 1 prior chemotherapy regimen)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN AST no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 4 weeks after study (during study and for 4 weeks after study for males) No peripheral neuropathy by history or clinical exam No uncontrolled infection

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 30 days since prior growth factors (i.e., epoetin alfa, filgrastim (G-CSF), sargramostim (GM-CSF), or thrombopoietic agent) for MDS No concurrent growth factors Chemotherapy: See Disease Characteristics At least 30 days since prior chemotherapy for MDS Endocrine therapy: At least 30 days since prior corticosteroids for MDS Concurrent chronic low-dose corticosteroids (less than 20 mg/day) for reasons other than MDS allowed Radiotherapy: Not specified Surgery: Not specified

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Canada
Administrative Information Fields
NCT ID  NCT00015990
Organization ID CDR0000068580
Secondary IDs †† NCCTG-N998B
Study Sponsor  North Central Cancer Treatment Group
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Alvaro Moreno Aspitia, MD     Mayo Clinic    
Information Provided By National Cancer Institute (NCI)
Verification Date February 2007
First Received Date  May 6, 2001
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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