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

Phase 2
18 Years
Open (Enrolling)
Bladder Cancer

Thank you

Trial Information

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

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.

Inclusion Criteria

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

- Adequate cardio-pulmonary function (< Class II ) as defined by New York Heart
Association Classification, at the time of screening, and no history of myocardial
infarction or heart failure within 6 months of start

- Laboratory test results within these ranges:

- Absolute neutrophil count ≥ 1500/mm³

- Platelet count ≥ 75,000

- Serum creatinine for which computed creatinine clearance is ≥ 30 ml/min, or
directly measured creatinine clearance ≥ 30 ml/min

- Total bilirubin ≤ 1.5 mg/dL

- Aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase [SGOT])
and Alanine transaminase (ALT) (serum glutamate pyruvic transaminase [SGPT]) ≤ 2
x upper limit of normal (ULN)

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2

Inclusion Criteria - Combination treatment:

- Prior BCG treatment for non-muscle invasive transitional cell carcinoma (TCC) last
administered < 2 years for Ta high-grade, T1 high grade, Cis, or combination thereof

- Must be registered into the mandatory RevAssist® program, and be willing and able to
comply with the requirements of RevAssist®

- Females of childbearing potential (FCBP)† must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to
and again within 24 hours of starting lenalidomide and must either commit to
continued abstinence from heterosexual intercourse or begin TWO acceptable methods of
birth control, one highly effective method and one additional effective method AT THE
SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also
agree to ongoing pregnancy testing. Men must agree to use a latex condom during
sexual contact with a FCBP even if they have had a successful vasectomy.

- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients
intolerant to aspirin may use warfarin or low molecular weight heparin.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Progression Free Survival (PFS)

Outcome Description:

The 1-year progression free/ recurrence free/ bladder-intact survival will be tabulated and the estimate and confidence interval will be computed. 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, which ever comes first.

Outcome Time Frame:

Duration of study treatment and follow-up - average of 12 months

Safety Issue:


Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

November 2011

Completion Date:

July 2015

Related Keywords:

  • Bladder Cancer
  • non-muscle-invasive
  • transitional cell
  • oral lenalidomide
  • intravesical
  • Urinary Bladder Neoplasms



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612