Conditions: Bladder Cancer
Keywords: non-muscle-invasive transitional cell oral lenalidomide intravesical
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 17
Healthy volunteers: no

Brief summary:
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

Detailed description:
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.

Arms:
arm 1: Bacille Calmette-Guerrin (BCG) and lenalidomide.

Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer. This group received BCG + lenalidomide) arm 2: Bacille Calmette-Guerrin (BCG) only.

Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer.

This group was not eligible to receive the combination of BCG + lenalidomide.

Interventions: intervention 1: Bacille Calmette-Guerrin (BCG) intervention 2: Lenalidomide
Intervention descriptions: intervention 1: Participants will receive BCG instillations once per week for the first 6 weeks. At 3 months and 6 months, participants will receive BCG instillations once per week for three weeks. intervention 2: Participants may also receive capsules of lenalidomide 10 mg to swallow once per day for 7 months. The study doctor will tell participants if they will be taking lenalidomide.

Protocol document: