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Oral Lenalidomide and Intravesical BCG for Therapy of Bladder Cancer

NCT01373294 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-08-06

Study results available
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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

Conditions

Interventions

DRUG

Bacille Calmette-Guerrin (BCG)

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.

DRUG

Lenalidomide

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.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Mayer Fishman, M.D., Ph.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-01-09
Completion
2018-12-10

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01373294 on ClinicalTrials.gov