On Trial

We are providing information on two different clinical trials for intravesical therapy for non-muscle invasive bladder cancer.

A Phase III Blinded Study of Immediate Post-TURBT Instillation of Gemcitabine versus Saline in Patients with Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer
The Southwest Oncology Group (SWOG), one of the largest cancer clinical trials cooperative groups in the United States, is currently enrolling patients for a low risk bladder cancer trial – S0337, “A Phase III Blinded Study of Immediate Post-TURBT Instillation of Gemcitabine versus Saline in Patients with Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer”.

Immediate post TURBT (trans-urethral resection of bladder tumor) intravesical instillation therapy has been shown to reduce recurrence of completely resected low risk bladder cancer (LRBC). Despite this, intravesical instillation therapy is rarely performed in the United States.  Gemcitabine has documented activity when administered systemically against advanced urothelial cancer and is well tolerated when given as intravesical treatment.

Eligible patients are those with newly diagnosed and occasionally recurrent urothelial cancer, believed to be at low risk (G1, G2, stage Ta, T1) for progression.  Eligibility for randomization will be based upon suspicion of study-eligible tumor grade and stage by the examining urologist, absence of prior grade 3, TIS, or T2+ cancers and no history of upper tract or prostatic urethral cancer.  End points are time to recurrence and progression.

For more information, please visit the SWOG website, www.swog.org, for a listing of institutions currently conducting the trial.

Predicting Response to Intravesical Therapy for Bladder Cancer
The majority of bladder tumors present as papillary lesions that can be resected endoscopically; however most of these tumors recur, and 10-20% progress to muscle-invasive disease.  To reduce the incidence of recurrence and progression, patients are treated with intravesical immunotherapy using Bacillus Calmette Guérin (BCG).  Although a large proportion of patients do respond to BCG, a significant number fail therapy.  Studies have shown that if intravesical therapy fails and cystectomy is required, patients who undergo surgery within 24 months of initial diagnosis have improved survival.  Thus early identification of patients in whom intravesical therapy will fail i.e., identification before the time of clinically apparent tumor recurrence, would permit earlier curative radical cystectomy and thus improve survival rates.

At present no reliable predictor of response to therapy yet exists.  At MD Anderson Cancer Center in Houston, Texas, Dr Ashish Kamat and colleagues have instituted a prospective trial to identify markers to predict response to immunotherapy, so that we do not delay offering curative surgery to those who will ultimately need it. In this clinical trial, Dr Kamat will first evaluate whether the persistence of cytogenetically abnormal cells in the urine after initiation of intravesical therapy (molecular recurrence) predicts clinical tumor recurrence.  Dr Kamat will also evaluate a panel of urinary cytokines to assess whether they correlate with patient response to intravesical immunotherapy. Finally, investigators will evaluate polymorphisms in genomic DNA isolated from peripheral blood of patients and correlate genetic profile with clinical outcome.

This article was contributed by Ashish Kamat, MD, Associate Professor and Fellowship Director, Department of Urology, M. D. Anderson Cancer Center.  If you have questions about this clinical trial, you may contact Dr Kamat’s research coordinators (Ms. Nancy Ainslie or Mr Roosevelt Anderson) at (713) 792-3250.