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Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
This study has been completed.

First Received on August 10, 2001.   Last Updated on April 6, 2011   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00022581
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: thalidomide
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Thalidomide (NSC# 66847, IND# 48832) for Patients With Relapsed or Refractory Low Grade Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:
  • Response rate [ Time Frame: 3 & 6 mon post tx start, q 6 mon ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
  • Effect on microvessel density in bone marrow and basic fibroblast growth factor levels in serum and urine [ Time Frame: 3 and 6 mon post tx start ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: July 2001
Study Completion Date: April 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: thalidomide
    200 mg
Detailed Description:

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.

  Eligibility

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

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022581

Locations
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Kansas
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States, 66204
United States, Michigan
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
United States, Missouri
Independence Regional Health Center
Independence, Missouri, United States, 64050
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States, 64108
St. Joseph Medical Center
Kansas City, Missouri, United States, 64114
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Parvin Radiation Oncology
Kansas City, Missouri, United States, 64116
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Hospital
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: David L. Grinblatt, MD NorthShore University HealthSystem Research Institute
  More Information

Additional Information:
Publications:
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.
Grinblatt DL, Johnson J, Niedzwicki D, et al.: Phase II study of thalidomide in escalating doses for follicular (F-NHL) and small lymphocytic lymphoma (Sll): CALGB study 50002. [Abstract] Blood 104 (11): A-3284, 2004.

Responsible Party: Monica M Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00022581     History of Changes
Other Study ID Numbers: CDR0000068832, U10CA031946, CALGB-50002
Study First Received: August 10, 2001
Last Updated: April 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cancer and Leukemia Group B:
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent small lymphocytic lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Thalidomide
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

ClinicalTrials.gov processed this record on February 12, 2012