Immune Modulation by Addition of Oral Lenalidomide to Intravesical BCG (Bacille Calmette-Guerrin) for Therapy of Non-muscle-invasive Transitional Cell Bladder Cancer
About 100 people with bladder cancer who are 18 years of age or older will be screened for
this study throughout the United States. It is expected that about 70 people will take part,
with 30 people at Moffitt Cancer Center.
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 bacilli calmette-guerin (BCG). BCG is approved by the
FDA for use in people with bladder cancer.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Progression Free Survival (PFS)
The 1-year progression free/ recurrence free/ bladder-intact survival will be tabulated and the estimate and confidence interval will be computed. The progression free/ recurrence free/ bladder-intact survival is defined as the time from start of study treatment to first documentation of objective tumor progression, recurrence, bladder resection or irradiation or to death due to any cause, which ever comes first.
Duration of study treatment and follow-up - average of 12 months
Mayer Fishman, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
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