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Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
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

MedlinePlus related topics:   Cancer    Lymphoma   

Drug Information available for:   Thalidomide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Trial of Thalidomide (NSC# 66847, IND# 48832) for Patients With Relapsed or Refractory Low Grade Non-Hodgkin's Lymphoma

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

Primary Outcome Measures:
  • 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 ]

Study Start Date:   July 2001

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, California
Kaiser Permanente Medical Office -Vandever Medical Office     Recruiting
      San Diego, California, United States, 92120
      Contact: Han A. Koh     619-528-2596        
United States, Indiana
CCOP - Northern Indiana CR Consortium     Recruiting
      South Bend, Indiana, United States, 46601
      Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Center for Cancer Therapy at LaPorte Hospital and Health Services     Recruiting
      La Porte, Indiana, United States, 46350
      Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Memorial Hospital of South Bend     Recruiting
      South Bend, Indiana, United States, 46601
      Contact: Clinical Trials Office - Memorial Hospital of South Bend     800-284-7370        
Howard Community Hospital     Recruiting
      Kokomo, Indiana, United States, 46904
      Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Elkhart General Hospital     Recruiting
      Elkhart, Indiana, United States, 46515
      Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Saint Joseph Regional Medical Center     Recruiting
      South Bend, Indiana, United States, 46617
      Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
South Bend Clinic     Recruiting
      South Bend, Indiana, United States, 46617
      Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
United States, Kansas
Johnson County Radiation Therapy     Recruiting
      Overland Park, Kansas, United States, 66210
      Contact: Rakesh Gaur, MD     816-823-0555        
Lawrence Memorial Hospital     Recruiting
      Lawrence, Kansas, United States, 66044
      Contact: Rakesh Gaur, MD     816-823-0555        
Menorah Medical Center     Recruiting
      Overland Park, Kansas, United States, 66209
      Contact: Rakesh Gaur, MD     816-823-0555        
Shawnee Mission Medical Center     Recruiting
      Shawnee Mission, Kansas, United States, 66204
      Contact: Rakesh Gaur, MD     816-823-0555        
United States, Michigan
Lakeland Regional Cancer Care Center - St. Joseph     Recruiting
      St. Joseph, Michigan, United States, 49085
      Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
United States, Missouri
CCOP - Kansas City     Recruiting
      Kansas City, Missouri, United States, 64131
      Contact: Rakesh Gaur, MD     816-823-0555        
Heartland Regional Medical Center     Recruiting
      Saint Joseph, Missouri, United States, 64506
      Contact: Rakesh Gaur, MD     816-823-0555        
Independence Regional Health Center     Recruiting
      Independence, Missouri, United States, 64050
      Contact: Rakesh Gaur, MD     816-823-0555        
Kansas City Cancer Center at St. Joseph's Medical Mall     Recruiting
      Kansas City, Missouri, United States, 64114
      Contact: Rakesh Gaur, MD     816-823-0555        
Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center     Recruiting
      Kansas City, Missouri, United States, 64154
      Contact: Rakesh Gaur, MD     816-823-0555        
Parvin Radiation Oncology     Recruiting
      Kansas City, Missouri, United States, 64116
      Contact: Rakesh Gaur, MD     816-823-0555        
North Kansas City Hospital     Recruiting
      Kansas City, Missouri, United States, 64116
      Contact: Rakesh Gaur, MD     816-823-0555        
Research Medical Center     Recruiting
      Kansas City, Missouri, United States, 64132
      Contact: Rakesh Gaur, MD     816-823-0555        
Saint Luke's Cancer Institute at Saint Luke's Hospital     Recruiting
      Kansas City, Missouri, United States, 64111
      Contact: Rakesh Gaur, MD     816-823-0555        
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis     Recruiting
      Saint Louis, Missouri, United States, 63110
      Contact: Nancy L. Bartlett, MD     314-362-5654        
St. Joseph Medical Center     Recruiting
      Kansas City, Missouri, United States, 64114
      Contact: Rakesh Gaur, MD     816-823-0555        
Truman Medical Center - Hospital Hill     Recruiting
      Kansas City, Missouri, United States, 64108
      Contact: Rakesh Gaur, MD     816-823-0555        
United States, North Carolina
Duke Comprehensive Cancer Center     Recruiting
      Durham, North Carolina, United States, 27710
      Contact: Clinical Trials Office - Duke Comprehensive Cancer Center     888-275-3853        
Pardee Memorial Hospital     Recruiting
      Hendersonville, North Carolina, United States, 28791
      Contact: James E. Radford, MD     828-692-8045        

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)

Investigators
Study Chair:     David L. Grinblatt, MD     Evanston Northwestern Healthcare - Evanston Hospital    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
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.
 

Study ID Numbers:   CDR0000068832, CALGB-50002
First Received:   August 10, 2001
Last Updated:   December 2, 2008
ClinicalTrials.gov Identifier:   NCT00022581
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent grade 1 follicular lymphoma  
recurrent grade 2 follicular lymphoma  
recurrent grade 3 follicular lymphoma  
recurrent small lymphocytic lymphoma  

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Thalidomide
Leukemia, B-cell, chronic
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma
Recurrence

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on December 03, 2008




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