drugset / Trial / NCT01094964

Hyperthermia and Mitomycin C, Bacillus Calmette-Guerin, or Standard Therapy as Second-Line Therapy in Treating Patients With Recurrent Bladder Cancer

NCT01094964

RandomizedOpen-labelTreatment

Summary

RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Drugs used in chemotherapy, such as mitomycin C and epirubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as bacillus calmette-guerin (BCG) and interferon alfa, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether giving hyperthermia together with mitomycin C is more effective than giving BCG or standard therapy as second-line therapy in treating patients with recurrent bladder cancer. PURPOSE: This randomized phase III trial is studying how well hyperthermia given together with mitomycin C works compared with BCG or standard therapy as second-line therapy in treating patients with recurrent bladder cancer.

Timeline

Start
2009-10
Primary completion
2013-10
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Mitomycin C Other / unclassified 40 mg Intravenous
Subject bacillus Calmette-Guérin Unknown Intravenous
Background Epirubicin Small molecule Intravenous
Background interferon alfa Protein / enzyme biologic Intravenous