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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2003-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Waldenstrom Macroglobulinemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Thalidomide

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No