Bladder Cancer Clinical Trial
Official title:
Immune Modulation by Addition of Oral Lenalidomide to Intravesical BCG (Bacille Calmette-Guerrin) for Therapy of Non-muscle-invasive Transitional Cell Bladder Cancer
The purposes of this study are to:
- find out whether participants' cancer returns or gets worse while they are taking
lenalidomide and Bacille Calmette-Guerrin (BCG);
- evaluate the safety and tolerability of the combination of lenalidomide and BCG;
- compare the cancer progression of participants taking lenalidomide and BCG versus
participants taking only BCG
Investigators planned to screen approximately 100 people with bladder cancer who are 18 years
of age or older throughout the United States for this study.
This is a multi-center study combining two marketed drugs, one of which has not been used
previously in people with transitional cell cancer. Lenalidomide (Revlimid®) is a drug that
alters the immune system and it may also interfere with the development of tiny blood vessels
that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of
cancer cells. Lenalidomide is approved by the U.S. Food and Drug Administration (FDA) for the
treatment of specific types of myelodysplastic syndrome (MDS) and in combination with
dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior
therapy. MDS and MM are cancers of the blood. Lenalidomide is currently being tested in a
variety of cancer conditions. It is not approved by the FDA for use in people with bladder
cancer, so in this case it is considered experimental.
The other drug used in this study is Bacille Calmette-Guerrin (BCG). BCG is approved by the
FDA for use in people with bladder cancer.
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