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Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia

2014-08-27 03:19:23 | BioPortfolio

Summary

The purpose of this research study is to determine the safety of RAD001(Everolimus) and the highest dose of this drug that can be given to people safely. RAD001(Everolimus) is a drug that works by preventing cells in the body from growing and dividing. Information from basic and Phase I clinical research studies suggests that RAD001 also may help to prevent tumor growth in people with relapsed or refractory lymphoma.

Description

- Participants will take RAD001 orally once a day in the morning. Each treatment cycle lasts for four weeks. Participants will receive up to 48 cycles of treatment.

- During each cycle, participants will be asked to visit the clinic for scheduled tests and exams. They will visit the clinic on the first day of each of the first three cycles, and then once every 3 cycles. During the visits, participants will have a physical exam and blood tests.. Participants may also have CT scans of the chest, abdomen and pelvis as well as a bone marrow aspirate and biopsy.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Waldenstrom's Macroglobulinemia

Intervention

RAD001

Location

Dana-Farber Cancer Institute
Boston
Massachusetts
United States
02115

Status

Recruiting

Source

Dana-Farber Cancer Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:23-0400

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Medical and Biotech [MESH] Definitions

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