DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: University of Arkansas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Waldenstrom Macroglobulinemia

Intervention: Thalidomide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Arkansas

Official(s) and/or principal investigator(s):
Athanasios Fassas, M.D., Principal Investigator, Affiliation: UAMS

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.

Clinical Details

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

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

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

Secondary outcome: To determine toxicities associated with thalidomide in patients with Waldenstrom's Macroglobulinemia

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University of Arkansas for Medical Sciences/MIRT, Little Rock, Arkansas 72205, United States
Additional Information

Myeloma Institute for Research & Therapy website

Starting date: January 1999
Last updated: July 1, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017