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.

Condition	Treatment or Intervention	Phase
refractory chronic lymphocytic leukemia B-cell Chronic Lymphocytic Leukemia	Drug: thalidomide  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: growth factor antagonist therapy	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Florida
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      CentraCare Health Plaza, Saint Cloud,  Minnesota,  56303,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
      Medcenter One Health System, Bismarck,  North Dakota,  58501,  United States
Ohio
      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States
Pennsylvania
      Allegheny General Hospital, Pittsburgh,  Pennsylvania,  15212-4772,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States
Canada, Saskatchewan
      Allan Blair Cancer Centre, Regina,  Saskatchewan,  S4T 7T1,  Canada

Study chairs or principal investigators

Neil E. Kay, MD,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000068148; NCCTG-N9986
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  September 11, 2000
ClinicalTrials.gov Identifier:  NCT00006226
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08