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Thalidomide With or Without Fludarabine in Treating Patients With Hematologic Cancer
This study has been completed.
First Received: February 2, 2001   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00009984
  Purpose

RATIONALE: Thalidomide may stop the growth of hematologic cancer by stopping blood flow to the cancer. Combining thalidomide with fludarabine may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drug. It is not yet known whether thalidomide is more effective with or without fludarabine for hematologic cancer.

PURPOSE: This randomized phase II trial is studying thalidomide and fludarabine to see how well they work compared to thalidomide alone in treating patients with hematologic cancer that has not responded to previous treatment with fludarabine.


Condition Intervention Phase
Leukemia
Lymphoma
Drug: fludarabine phosphate
Drug: thalidomide
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
Drug Information available for: Thalidomide Fludarabine Fludarabine monophosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: Randomized Phase II Study Of Thalidomide Versus Thalidomide Plus Fludarabine For Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine

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

Primary Outcome Measures:
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Incidence of complete and partial remission [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: March 2001
Detailed Description:

OBJECTIVES:

  • Compare the safety and tolerability of thalidomide with or without fludarabine in patients with fludarabine-refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
  • Compare the incidence of complete and partial remission in patients treated with these regimens.

OUTLINE: This is a randomized, open-label study. Patients are stratified according to time to relapse from last fludarabine treatment (less than 6 months vs more than 6 months). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive thalidomide as in arm I and fludarabine IV over 30 minutes on days 1-5. Treatment with fludarabine repeats every 28 days for 6 courses. Once fludarabine is completed, patients continue to receive thalidomide alone as in arm I.

PROJECTED ACCRUAL: A total of 24-70 patients (12-35 per treatment arm) will be accrued for this study within 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of one of the following:

    • Confirmed chronic lymphocytic leukemia (CLL), meeting the following criteria:

      • Peripheral blood lymphocytosis greater than 5,000/mm^3
      • Co-expression of the CD5, CD19, CD20, and CD23 surface antigens
      • Clonal kappa and lambda light chain expression
      • Dim surface immunoglobulin expression
    • Small lymphocytic lymphoma
  • Relapsed or refractory disease

    • Must have received at least 1 prior regimen containing fludarabine
    • Meets one of the following criteria:

      • Recurrence of lymphocytosis greater than 5,000/mm^3 or an increase in lymph node volume greater than 50% after achieving complete (CR) or partial response (PR)
      • Never achieved a CR or PR after receiving at least 2 courses of fludarabine IV for 5 days at a dose of 25 mg/m^2/day
  • No other lymphoproliferative diseases or diseases due to transformation of CLL (e.g., prolymphocytic leukemia or Richter's syndrome)
  • No known CNS disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin < 2.0 times upper limit of normal (ULN)*
  • SGOT < 2.5 times ULN* NOTE: *Unless due to Gilbert's disease OR the result of CLL

Renal:

  • Creatinine < 1.5 times ULN

Cardiovascular:

  • No history of cardiac arrhythmia
  • No myocardial infarction within the past 6 months

Other:

  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
  • No active serious infection uncontrolled by antibiotics
  • No pre-existing neurotoxicity grade 3 or greater
  • No other medical condition that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Female patients must use 2 effective methods (at least 1 highly active method) of contraception 4 weeks before, during, and for 4 weeks after study participation and male patients must use effective barrier contraception during and for 4 weeks after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy and recovered
  • No concurrent growth factors (epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF])

Chemotherapy:

  • See Disease Characteristics
  • No more than 3 prior chemotherapy regimens
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • Recovered from any prior investigational agents
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00009984

Locations
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States, 11030
Mount Sinai Medical Center
New York, New York, United States, 10029
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Study Chair: Richard R. Furman, MD Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068429, NYWCCC-MTS-00-0535ME, NCI-639
Study First Received: February 2, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00009984     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
refractory chronic lymphocytic leukemia
recurrent small lymphocytic lymphoma

Study placed in the following topic categories:
Antimetabolites
Leukemia, Lymphoid
Immunoproliferative Disorders
Immunologic Factors
Hematologic Neoplasms
Thalidomide
Fludarabine monophosphate
Angiogenesis Inhibitors
Immunosuppressive Agents
Recurrence
Anti-Bacterial Agents
Leukemia
Lymphatic Diseases
Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Fludarabine
Leukemia, B-Cell
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic
Lymphoma

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

ClinicalTrials.gov processed this record on May 06, 2009