Overview

This trial is active, not recruiting.

Condition bladder cancer
Treatments bacilli calmette-guerin (bcg), lenalidomide
Phase phase 2
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator Celgene Corporation
Start date November 2011
End date June 2016
Trial size 17 participants
Trial identifier NCT01373294, MCC-16295, RV-BLD-PI-0330

Summary

The purposes of this study are to:

- find out whether participants' cancer returns or gets worse while they are taking lenalidomide and bacilli calmette-guerin (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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will be assigned to receive BCG or BCG and lenalidomide based on their cancer.
bacilli calmette-guerin (bcg) 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.
(Experimental)
Participants will be assigned to receive BCG or BCG and lenalidomide based on their cancer.
bacilli calmette-guerin (bcg) 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.
lenalidomide Revlimid®
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.

Primary Outcomes

Measure
Number of Participants with Progression Free Survival (PFS)
time frame: 1 year

Secondary Outcomes

Measure
Number of Participants With Serious Adverse Events (SAEs)
time frame: Duration of study treatment and follow-up - average of 12 months
Number of Participants Showing Effect of Addition of Revlimid on Cytokines
time frame: Duration of study treatment and follow-up - average of 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria - Either control group or combination treatment: - Understand and voluntarily sign an informed consent form - Able to adhere to the study visit schedule and other protocol requirements - Ta high grade, T1 high grade or Tis transitional cell bladder cancer, s/p transurethral resection of bladder tumor (TURBT) with no remaining resectable disease - Adequate cardio-pulmonary function (

Additional Information

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
Principal investigator Mayer Fishman, M.D., Ph.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.