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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), June 2009
First Received: August 10, 2001   Last Updated: June 30, 2009   History of Changes
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

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

Resource links provided by NLM:


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
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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
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        
Elkhart General Hospital Recruiting
Elkhart, Indiana, United States, 46515
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Howard Community Hospital Recruiting
Kokomo, Indiana, United States, 46904
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        
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
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        
Truman Medical Center - Hospital Hill Recruiting
Kansas City, Missouri, United States, 64108
Contact: Rakesh Gaur, MD     816-823-0555        
Independence Regional Health Center Recruiting
Independence, Missouri, United States, 64050
Contact: Rakesh Gaur, MD     816-823-0555        
Liberty Hospital Recruiting
Liberty, Missouri, United States, 64068
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        
Parvin Radiation Oncology 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        
Saint Luke's East - Lee's Summit Recruiting
Lee's Summit, Missouri, United States, 64086
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        
Heartland Regional Medical Center Recruiting
Saint Joseph, Missouri, United States, 64506
Contact: Rakesh Gaur, MD     816-823-0555        
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: David L. Grinblatt, MD Evanston NorthShore University HealthSystem
  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.

Study ID Numbers: CDR0000068832, CALGB-50002
Study First Received: August 10, 2001
Last Updated: June 30, 2009
ClinicalTrials.gov Identifier: NCT00022581     History of Changes
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:
Immunoproliferative Disorders
Immunologic Factors
Thalidomide
Lymphoma, Follicular
Angiogenesis Inhibitors
Immunosuppressive Agents
Follicular Lymphoma
Recurrence
Lymphoma, Small Cleaved-cell, Diffuse
Anti-Bacterial Agents
Lymphatic Diseases
Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic
Lymphoma

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Thalidomide
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Leprostatic Agents

ClinicalTrials.gov processed this record on July 02, 2009