Oral Lenalidomide and Intravesical BCG for Therapy of Bladder Cancer
Completed · Phase 2
Conditions studied: Bladder Cancer
In brief
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
Key facts
- Study ID
- NCT01373294
- Run by
- H. Lee Moffitt Cancer Center and Research Institute
- People needed
- 17
- Starts
- 2011-11-30
- Expected to finish
- 2018-12-10
- Last updated by the study team
- 2019-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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