CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Bacille Calmette-Guerrin (BCG) +1 moredrug
Likely dose
Lenalidomide 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01373294
NCT01373294Phase 2Completed
CompareCT.gov

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

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Jun 14, 2011·Updated Aug 6, 2019

In Brief

A Phase 2 clinical trial evaluating Bacille Calmette-Guerrin (BCG) and Lenalidomide for Bladder Cancer. Completed, enrolled 17 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesUnited States
CollaboratorsCelgene Corporation

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2011
Enrollment StartNov 30, 2011
Primary CompletionJan 9, 2015
Study CompletionDec 10, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.0 years ago

Interventions

Bacille Calmette-Guerrin (BCG)drug

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.

Lenalidomidedrug

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.