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Home > "T" Clinical Trials Conditions > Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia  Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
For Condition: B-cell Chronic Lymphocytic Leukemia,refractory chronic lymphocytic leukemia
Status: No longer recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Thalidomide may stop the growth of chronic lymphocytic leukemia by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed chronic lymphocytic leukemia.
Details: OBJECTIVES: - Determine the objective response in patients with relapsed chronic lymphocytic leukemia treated with thalidomide. - Determine the toxicity of this drug in these patients. - Determine the correlation between vascular growth factors and/or bone marrow angiogenesis patterns and thalidomide-related clinical response in these patients. OUTLINE: Patients receive oral thalidomide daily for 4 weeks. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years. PROJECTED ACCRUAL: A total of 12-41 patients will be accrued for this study within 28 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of chronic lymphocytic leukemia (CLL) evidenced by monoclonal population of mature CD5+, CD19+, CD23+, and B cells - Relapsed after prior treatment for CLL - Active disease with 1 or more of the following characteristics: - At least 10% weight loss within the past 6 months - Fever greater than 100.5 degrees F for at least 2 weeks without evidence of infection - Night sweats without evidence of infection - Evidence of progressive marrow failure with anemia (hemoglobin less than 11 g/dL) and/or thrombocytopenia (platelet count less than 100,000/mm^3) (i.e., any stage III or IV disease) - Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy - Massive or progressive splenomegaly (i.e., greater than 6 cm below the left costal margin or more than 50% increase over 2 months) - Progressive lymphadenopathy (i.e., more than 50% increase over 2 months) - Progressive lymphocytosis (not due to corticosteroids) with an increase of more than 50% over a 2-month period or an anticipated doubling time of less than 6 months - Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not considered evidence of active disease - Measurable disease - Absolute lymphocyte count greater than 5,000/mm^3 - No bulky lymph node disease greater than 10 cm in at least 1 dimension except splenomegaly PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - Absolute neutrophil count at least 500/mm^3 - Platelet count at least 20,000/mm^3 (in absence of sargramostim [GM-CSF]) - Hemoglobin at least 8 g/dL Hepatic: - Bilirubin no greater than 2.5 times upper limit of normal (ULN) - AST no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Other: - No other active malignancy - No peripheral neuropathy (sensory) grade 2 or greater - No active infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 1 highly effective method of contraception AND 1 additional effective method of contraception for at least 4 weeks before, during, and for 4 weeks after study completion PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior allogeneic bone marrow transplantation - At least 10 days since prior filgrastim (G-CSF) or GM-CSF Chemotherapy: - No more than 3 prior chemotherapy regimens - At least 30 days since prior chemotherapy Endocrine therapy: - See Disease Characteristics - No concurrent corticosteroids except for adrenal insufficiency Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NeilKay, Study Chair, Mayo Clinic Cancer Center
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Additional Information:
Study ID Numbers: CDR0000068148; NCCTG-N9986
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006226
Other Refractory Chronic Lymphocytic Leukemia Studies:
1. High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
2. 506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents
3. FR901228 in Treating Children with Refractory or Recurrent Solid Tumors or Leukemia
4. Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
5. Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, or Multiple Myeloma
Related Studies:
Other refractory chronic lymphocytic leukemia Clinical Trials
Other South Dakota Clinical Trials
Other Rapid City Clinical Trials
Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
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