Oral Lenalidomide and Intravesical BCG for Therapy of Bladder Cancer

Phase 2

Completed

Conditions: Bladder Cancer

Interventions: Drug: Bacille Calmette-Guerrin (BCG)
Drug: Lenalidomide

Registration Number: NCT01373294

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from providing informed consent
Pregnant or breast feeding (lactating females must agree not to breast feed while taking lenalidomide)
Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
Use of any other experimental drug or therapy within 28 days of baseline
Known hypersensitivity to thalidomide
Known hypersensitivity to BCG or tuberculosis vaccination
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Any prior use of lenalidomide
Concurrent use of other anti-cancer agents or treatments.
Known presence of autoimmune disease or immune deficit or chronic disease such as HIV, infectious hepatitis (type B or C), or tuberculosis
T2+, or N1+, or M+ disease
Ta or T1 low grade disease only
Concurrent use of chronic oral steroids, for any indication
Recent history of deep venous thrombosis currently receiving anticoagulation therapy, with the clot event being in the last 6 months
Diagnosis of any prior malignancies for the last 5 years with exception of definitively treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast
Life expectancy less than 1 year, by treating physician estimate
Known exposure to person with active tuberculosis within 48 hours of starting treatment

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: Combination Arm	Lenalidomide	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)
A: Combination Arm	Bacille Calmette-Guerrin (BCG)	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)
B: Control Arm	Bacille Calmette-Guerrin (BCG)	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.

Primary Outcome Measures

Name	Time	Method
Arm A: Progression Free Survival (PFS)	1 year	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

Secondary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	Duration of study treatment and follow-up - average of 12 months	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.