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| Tracking Information | |||||
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| First Received Date ICMJE | May 6, 2001 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | April 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00015990 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Thalidomide in Treating Patients With Myelodysplastic Syndrome | ||||
| Official Title ICMJE | 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. |
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| 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) |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: thalidomide | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Moreno-Aspitia A, Colon-Otero G, Hoering A, Tefferi A, Niedringhaus RD, Vukov A, Li CY, Menke DM, Geyer SM, Alberts SR; North Central Cancer Treatment Group. Thalidomide therapy in adult patients with myelodysplastic syndrome. A North Central Cancer Treatment Group phase II trial. Cancer. 2006 Aug 15;107(4):767-72. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00015990 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068580, NCCTG-N998B | ||||
| Study Sponsor ICMJE | North Central Cancer Treatment Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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