NCT01373294

Oral Lenalidomide and Intravesical BCG for Therapy of Bladder Cancer

Immune Modulation by Addition of Oral Lenalidomide to Intravesical BCG (Bacille Calmette-Guerrin) for Therapy of Non-muscle-invasive Transitional Cell Bladder Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Bacille Calmette-Guerrin (BCG)	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.
DRUG	Lenalidomide	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.

Timeline

• Start date: 2011-11-30
• Primary completion: 2015-01-09
• Completion: 2018-12-10
• First posted: 2011-06-14
• Last updated: 2019-08-06
• Results posted: 2016-05-12

Locations

1 site across 1 country: United States