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Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Dana-Farber Cancer Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Cape Cod Healthcare
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00142116
First received: September 1, 2005
Last updated: December 23, 2007
Last verified: December 2007
History of Changes
  Purpose

The purpose of this study is to determine the percentage of people who can attain remission and the length of time such responses to therapy are sustained, as well as the side effects that might result from rituximab and thalidomide in people with lymphoplasmacytic lymphoma.


Condition Intervention Phase
Waldenstrom's Macroglobulinemia
Lymphoplasmacytic Lymphoma
 Drug: Thalidomide
Drug: Rituximab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To define objective response to time to treatment failure, and toxicity for combined thalidomide and rituximab therapy in Waldenstrom's macroglobulinemia patients. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify the mechanism(s) of action for combined thalidomide and rituximab activity. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: May 2003
Estimated Study Completion Date: February 2008
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Thalidomide
    200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks.
    Drug: Rituximab
    Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated will, this may be repeated 8 weeks later.
Detailed Description:
  • Patients will receive thalidomide(200mg) orally once daily for two weeks. If after two weeks of thalidomide, the patient is doing well the dose of thalidomide will increase (400mg) and they will remain on it for up to 50 additional weeks. The length of time a patient is on thalidomide will depend upon how they are responding to therapy.
  • During the second week of the study patients will also begin receiving rituximab intravenously once weekly for 4 weeks, which may then be repeated 8 weeks later depending upon the response.
  • A determination of how the patient is responding will be made based on testing conducted at 12 weeks. This testing includes blood tests and possibly a bone marrow biopsy. If it is determined that the disease is not progressing, patients will begin a second phase of treatment which includes 4 additional weekly infusions of rituximab and the continuation of oral thalidomide.
  • If it is determined at the 12-week evaluation, or at any time thereafter, that the disease has progressed (by studying serum IgM levels, bone marrow involvement, tumor cells, and/or development of new signs and symptoms) then the patient will be removed from the study.
  • Periodic examinations and tests will be done to determine how the patient is doing, what response and side effects (if any) the patient may be having from the study drugs. If patient is responding to therapy then they will remain on this study and followed for a period of two years.
  • Bone marrow biopsies and aspirations will be obtained at 3-6 month intervals extending for 2 years following the last treatment.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinicopathological diagnosis of Waldenstrom's macroglobulinemia requiring therapy
  • Baseline staging requirements
  • ANC > 500/uL
  • PLT > 25,000/uL
  • Serum creatinine < 2.5mg/dL
  • Total bilirubin and SGOT < 2.5 X ULN
  • Greater than 18 years of age
  • Life expectancy of 3 months or greater
  • ECOG status performance of 0-2

Exclusion Criteria:

  • Chemotherapy, steroid therapy, or radiation therapy within 30 days of study entry
  • Pregnant or lactating women
  • Serious co-morbid disease
  • Uncontrolled bacterial, fungal or viral infection
  • Active second malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142116

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Cape Cod Healthcare
Investigators
Principal Investigator: Steven P. Treon, MD, MA, PhD Dana-Farber Cancer Institute
  More Information

No publications provided by Dana-Farber Cancer Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven P. Treon, MD, MA, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00142116     History of Changes
Other Study ID Numbers: 03-077
Study First Received: September 1, 2005
Last Updated: December 23, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
thalidomide
rituximab
Waldenstrom's

Additional relevant MeSH terms:
Lymphoma
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
 Hemorrhagic Disorders
Thalidomide
Rituximab
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

ClinicalTrials.gov processed this record on May 22, 2013