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

Waldenstrom Macroglobulinemia Clinical Trial

Official title:

UARK 99-006, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom's Macroglobulinemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00083707
• Other study ID #: UARK 99-006
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2004
• Last updated: July 1, 2010
• Start date: January 1999
• Est. completion date: February 2003

Study information

• Verified date: July 2010
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia

Intervention

Drug:
• Thalidomide

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences/MIRT	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine tumor response, overall and progression free survival following thalidomide therapy in patients with Waldenstrom's Macroglobulinemia (WM)
Secondary	To determine toxicities associated with thalidomide in patients with Waldenstrom's Macroglobulinemia

External Links

•   Myeloma Institute for Research & Therapy website