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

Primary Purpose

Waldenstrom Macroglobulinemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
University of Arkansas
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Waldenstrom Macroglobulinemia focused on measuring Macroglobulinemia, Waldenstrom, Thalidomide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Arkansas for Medical Sciences/MIRT

Outcomes

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

Full Information

First Posted
May 27, 2004
Last Updated
July 1, 2010
Sponsor
University of Arkansas
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00083707
Brief Title
Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom's Macroglobulinemia
Official Title
UARK 99-006, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom's Macroglobulinemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Arkansas
Collaborators
Celgene Corporation

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenstrom Macroglobulinemia
Keywords
Macroglobulinemia, Waldenstrom, Thalidomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Thalidomide
Primary Outcome Measure Information:
Title
To determine tumor response, overall and progression free survival following thalidomide therapy in patients with Waldenstrom's Macroglobulinemia (WM)
Secondary Outcome Measure Information:
Title
To determine toxicities associated with thalidomide in patients with Waldenstrom's Macroglobulinemia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athanasios Fassas, M.D.
Organizational Affiliation
UAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences/MIRT
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Links:
URL
http://myeloma.uams.edu
Description
Myeloma Institute for Research & Therapy website

Learn more about this trial

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

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