Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Vaccines

Lenalidomide

BCG Vaccine

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Adjuvants, Immunologic

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)

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.

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.

Bacille Calmette-Guerrin (BCG)

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.

Mayer Fishman, M.D., Ph.D.

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.

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

The immunologic impact of the addition of Revlimid™ to BCG for secondary prevention of non-muscle-invasive transitional cell bladder cancer, in terms of a panel of correlative assays. The effect of addition of Revlimid on cytokines associated with generation of immune response and on cytotoxic T lymphocytes and memory phenotype lymphocytes.

For comparing the correlative assay results of ever-relapsers vs non-relapsers, the combined data with the monotherapy and combination therapy groups would be applied. The participants would be categorized based on 1-year relapse.

The 1-year progression free/ recurrence free/ bladder-intact survival was tabulated for the experimental arm for a median follow-up period of 369 days. 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, whichever comes first. PFS data was not collected for participants in the Arm B: Control because too few participants were enrolled in Arm B to conduct the planned per Arm comparison

Number of participants with treatment emergent AEs or SAEs per category. SAEs will be specifically labeled as such. Participants were assessed at monthly intervals (corresponding to Revlimid™ refill points for adverse events), classified by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and these were tabulated.

Celgene Corporation

H. Lee Moffitt Cancer Center and Research Institute

Bacille Calmette-Guerrin (BCG) and lenalidomide.

A: Combination Arm

B: Control Arm

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

The Primary Outcome Measure addresses Arm A only, whose participants received the experimental drug. Too few participants were enrolled into Arm B to conduct the planned per arm comparison. Demographic details and Adverse Events have been reported for all participants in both arms.

This study closed to accrual early, due to slow accrual. Too few participants were enrolled into Arm B to conduct the planned per arm comparisons.

Spots Global Cancer Trial Database for transitional cell