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Thalidomide With or Without Fludarabine in Treating Patients With Hematologic Cancer

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00009984
First received: February 2, 2001
Last updated: June 5, 2013
Last verified: June 2013
History of Changes
  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. 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.


Condition Intervention Phase
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
 Drug: fludarabine phosphate
Drug: thalidomide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Thalidomide Versus Thalidomide Plus Fludarabine for Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of complete and partial remission [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: March 2002
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (thalidomide)
Patients receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity.
 Drug: thalidomide
Given orally
Other Names:
  • Kevadon
  • Synovir
  • THAL
  • Thalomid
Experimental: Arm II (thalidomide, fludarabine phosphate)
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.
 Drug: fludarabine phosphate
Given IV
Other Names:
  • 2-F-ara-AMP
  • Beneflur
  • Fludara
Drug: thalidomide
Given orally
Other Names:
  • Kevadon
  • Synovir
  • THAL
  • Thalomid

Detailed Description:

OBJECTIVES:

I. Compare the safety and tolerability of thalidomide with or without fludarabine in patients with fludarabine-refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

II. 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

Inclusion Criteria:

  • 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
  • Performance status - Karnofsky 60-100%
  • At least 12 weeks
  • See Disease Characteristics
  • Bilirubin < 2.0 times upper limit of normal (ULN)*
  • SGOT < 2.5 times ULN*
  • Creatinine < 1.5 times ULN
  • No history of cardiac arrhythmia
  • No myocardial infarction within the past 6 months
  • 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
  • At least 4 weeks since prior biologic therapy and recovered
  • No concurrent growth factors (epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF])
  • 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
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy
  • 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
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Richard Furman Montefiore Medical Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00009984     History of Changes
Other Study ID Numbers: NCI-2012-02393, NYWCCC-MTS-00-0535ME, CDR0000068429, NCI-639, N01CM62204
Study First Received: February 2, 2001
Last Updated: June 5, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 13, 2013