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Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
This study has been completed.
Study NCT00022581   Information provided by National Cancer Institute (NCI)
First Received: August 10, 2001   Last Updated: August 13, 2009   History of Changes

August 10, 2001
August 13, 2009
July 2001
October 2007   (final data collection date for primary outcome measure)
  • Response rate [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Effect on microvessel density in bone marrow and basic fibroblast growth factor levels in serum and urine [ Designated as safety issue: No ]
  • Response rate
  • Time to progression
  • Effect on microvessel density in bone marrow and basic fibroblast growth factor levels in serum and urine
Complete list of historical versions of study NCT00022581 on ClinicalTrials.gov Archive Site
 
 
 
Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase II Trial of Thalidomide (NSC# 66847, IND# 48832) for Patients With Relapsed or Refractory Low Grade Non-Hodgkin's Lymphoma

RATIONALE: Thalidomide may stop the growth of non-Hodgkin's lymphoma by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed or refractory low-grade non-Hodgkin's lymphoma.

OBJECTIVES:

  • Determine the response rate and time to progression in patients with relapsed or refractory low-grade non-Hodgkin's lymphoma treated with thalidomide.
  • Determine the effect of this drug on microvessel density in bone marrow and basic fibroblast growth factor levels in serum and urine in these patients.

OUTLINE: Patients receive oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study.

Phase II
Interventional
Treatment, Open Label
Lymphoma
Drug: thalidomide
 
Smith SM, Grinblatt D, Johnson JL, Niedzwiecki D, Rizzieri D, Bartlett NL, Cheson BD; Cancer and Leukemia Group B. Thalidomide has limited single-agent activity in relapsed or refractory indolent non-Hodgkin lymphomas: a phase II trial of the Cancer and Leukemia Group B. Br J Haematol. 2008 Feb;140(3):313-9.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
October 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed relapsed or refractory low-grade non-Hodgkin's lymphoma of 1 of the following subtypes:

    • Follicular grades I, II, or III
    • B-cell small lymphocytic lymphoma
  • Bidimensionally measurable disease

    • Greater than 1 cm in each dimension by physical exam, x-ray, MRI, or CT scan
    • The following are not considered measurable:

      • Barium studies
      • Ascites or pleural effusions
      • Bony disease
      • Bone marrow
  • No marginal zone lymphoma
  • No known lymphomatous involvement of the CNS, including parenchymal or leptomeningeal involvement NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1 OR
  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 750/mm^3

Hepatic:

  • Bilirubin normal
  • AST and ALT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 2 times normal

Neurologic:

  • No seizure disorders
  • No prior brain injury that would precipitate seizures
  • No peripheral neuropathy greater than grade 1

Other:

  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Regardless of fertility status:

    • Female patients must use at least 1 highly active method of contraception AND 1 additional effective method of contraception for 4 weeks before, during, and for 4 weeks after study participation
  • Male patients must use effective barrier contraception during and for 4 weeks after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No more than 2 prior antibody treatments

Chemotherapy:

  • No more than 3 prior chemotherapy regimens
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except steroids for adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes)
  • No concurrent dexamethasone or other steroidal antiemetics

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No concurrent bisphosphonates (e.g., zoledronate)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00022581
 
CDR0000068832, CALGB-50002
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: David L. Grinblatt, MD NorthShore University HealthSystem Research Institute
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP