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Thalidomide in Treating Patients With Myelodysplastic Syndrome Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Thalidomide in Treating Patients With Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Thalidomide in Treating Patients With Myelodysplastic Syndrome Clinical research trials and Thalidomide in Treating Patients With Myelodysplastic Syndrome medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Thalidomide in Treating Patients With Myelodysplastic Syndrome. Thalidomide in Treating Patients With Myelodysplastic Syndrome Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Thalidomide in Treating Patients With Myelodysplastic Syndrome clinical trial. Participants oftentimes recieve the finest healthcare available for their Thalidomide in Treating Patients With Myelodysplastic Syndrome condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Thalidomide in Treating Patients With Myelodysplastic Syndrome  Thalidomide in Treating Patients With Myelodysplastic Syndrome
Thalidomide in Treating Patients With Myelodysplastic Syndrome
For Condition: refractory anemia with excess blasts,refractory anemia with ringed sideroblasts,Chronic Myelomonocytic Leukemia,previously treated myelodysplastic syndromes,de novo myelodysplastic syndromes,Refractory Anemia,secondary myelodysplastic syndromes,refractory anemia with excess blasts in transformation
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: 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.
Details: OBJECTIVES: I. Determine whether thalidomide improves cytopenias in patients with myelodysplastic syndrome. 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. PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to prognosis (favorable vs unfavorable). 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of myelodysplastic syndrome (MDS) in the bone marrow; 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: Pre-transfusion hemoglobin no greater than 10 g/dL; Pre-transfusion 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) --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GerardoColon-Otero, Study Chair, North Central Cancer Treatment Group
Medcenter One Health System
Bismark, North Dakota, 58501
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
Additional Information:
Study ID Numbers: CDR0000068580; NCCTG-N998B
Study Start Date: April 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015990
Other Refractory Anemia Studies:
1. Decitabine Compared With Supportive Care in Treating Patients With Advanced Myelodysplastic Syndromes
2. Thalidomide in Treating Anemia in Patients With Myelodysplastic Syndrome
3. Tipifarnib in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome in Complete Remission
4. VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies
5. Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Related Studies:
Other Refractory Anemia Clinical Trials
Other Minnesota Clinical Trials
Other St. Cloud Clinical Trials
Thalidomide in Treating Patients With Myelodysplastic Syndrome
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