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

This study has been completed.

First Received: May 27, 2004 Last Updated: November 9, 2005 History of Changes

Sponsors and Collaborators:	University of Arkansas Celgene Corporation
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00083707

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

Drug Information available for: Thalidomide

U.S. FDA Resources

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:

Myeloma Institute for Research & Therapy website This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	UARK 99-006
Study First Received:	May 27, 2004
Last Updated:	November 9, 2005
ClinicalTrials.gov Identifier:	NCT00083707 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Arkansas:

Macroglobulinemia
Waldenstrom
Thalidomide

Study placed in the following topic categories:

Anti-Infective Agents
Immunoproliferative Disorders
Immunologic Factors
Thalidomide
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Angiogenesis Inhibitors
Immunosuppressive Agents
Anti-Bacterial Agents
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Hemorrhagic Disorders
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Infective Agents
Thalidomide
Immunologic Factors
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Paraproteinemias
Hemostatic Disorders
Anti-Bacterial Agents
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Neoplasms by Histologic Type

Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Growth Substances
Vascular Diseases
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Waldenstrom Macroglobulinemia
Lymphoproliferative Disorders
Neoplasms, Plasma Cell
Leprostatic Agents

ClinicalTrials.gov processed this record on September 03, 2009