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Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
This study has been completed.
First Received: September 11, 2000   Last Updated: July 23, 2008   History of Changes
Sponsor: North Central Cancer Treatment Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006226
  Purpose

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 Intervention Phase
Leukemia
Drug: thalidomide
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial of Thalidomide in Patients With Relapsed Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2000
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006226

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

Additional Information:
No publications provided

Study ID Numbers: CDR0000068148, NCCTG-N9986
Study First Received: September 11, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006226     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia

Additional relevant MeSH terms:
Anti-Infective Agents
Leukemia, Lymphoid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Thalidomide
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Leukemia
Lymphatic Diseases
Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Leukemia, B-Cell
Lymphoproliferative Disorders
Leprostatic Agents

ClinicalTrials.gov processed this record on November 09, 2009