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


Phase 2
18 Years
N/A
Not Enrolling
Both
Waldenstrom Macroglobulinemia

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Athanasios Fassas, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UAMS

Authority:

United States: Food and Drug Administration

Study ID:

UARK 99-006

NCT ID:

NCT00083707

Start Date:

January 1999

Completion Date:

February 2003

Related Keywords:

  • Waldenström Macroglobulinemia
  • Macroglobulinemia
  • Waldenstrom
  • Thalidomide
  • Waldenstrom Macroglobulinemia

Name

Location

University of Arkansas for Medical Sciences/MIRTLittle Rock, Arkansas  72205