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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Given orally
Correlative studies
North Central Cancer Treatment Group
Rochester, Minnesota, United States
Confirmed response defined as complete hematologic response (CHR) or partial response (PR) or hematological improvement (HI) on 2 consecutive evaluations in terms of proportion of successes measured using criteria reported by Cheson et al
Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Time frame: Up to 3 months
Incidence and severity of toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Time frame: Up to 5 years
Survival time
Estimated using the method of Kaplan-Meier.
Time frame: Time from registration to death due to any cause, assessed up to 5 years
Time to disease progression
Estimated using the method of Kaplan-Meier.
Time frame: Time from registration to documentation of disease progression, assessed up to 5 years
Duration of response measured using criteria reported by Cheson et al
Time frame: Date at which the patient's objective status is first noted to be either a CHR or PR to the date progression is documented, assessed up to 5 years
Time to treatment failure
Time frame: Time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.