Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom's Macroglobulinemia

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00083707
First received: May 27, 2004
Last updated: July 1, 2010
Last verified: July 2010
  Purpose

The purpose of this research is to study how helpful thalidomide is in controlling the disease and to study any side effects from taking thalidomide.


Condition Intervention Phase
Waldenstrom Macroglobulinemia
Drug: Thalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: UARK 99-006, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom's Macroglobulinemia

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • To determine tumor response, overall and progression free survival following thalidomide therapy in patients with Waldenstrom's Macroglobulinemia (WM)

Secondary Outcome Measures:
  • To determine toxicities associated with thalidomide in patients with Waldenstrom's Macroglobulinemia

Estimated Enrollment: 40
Study Start Date: January 1999
Estimated Study Completion Date: February 2003
Detailed Description:

Patients will receive thalidomide in the oral form each night before bed. The dose of thalidomide will be increased each week until week 7 as long as there are no significant side effects.

Routine physical examinations and blood tests will be done to monitor the effect of treatment and the toxicities encountered, if any, and provide the available treatments for side effects accordingly. Blood tests will be done to monitor the tumor response.

  Eligibility

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

Inclusion Criteria:

  • Patients must have a confirmed diagnosis of previously treated, active Waldenstrom's Macroglobulinemia
  • Patients must have adequate hematologic function as demonstrated by total white blood count > or = 2000/mm3, adequate renal function as demonstrated by serum creatinine < or = 3.0 mg/dl, and adequate hepatic function as demonstrated by bilirubin < or = 1.5 mg/dl and transaminases < or = 4 x ULN
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

  • No other concurrent therapy for WM is permitted while on thalidomide
  • Pregnant or nursing women may not participate. Before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy. Written report of a negative pregnancy test must be obtained before a prescription for thalidomide is issued. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Pregnancy testing is not required for 1) women who have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083707

Locations
United States, Arkansas
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Celgene Corporation
Investigators
Principal Investigator: Athanasios Fassas, M.D. UAMS
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00083707     History of Changes
Other Study ID Numbers: UARK 99-006
Study First Received: May 27, 2004
Last Updated: July 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arkansas:
Macroglobulinemia
Waldenstrom
Thalidomide

Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
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 April 23, 2014