NCT02944357

Gemcitabine Hydrochloride, Cisplatin, and AGS-003-BLD in Treating Patients With Muscle-Invasive Bladder Cancer Undergoing Surgery

Pilot Study of Gemcitabine and Cisplatin Plus AGS-003-BLD in Patients With Muscle-Invasive Bladder Cancer Undergoing Neoadjuvant Cisplatin-Based Chemotherapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies how well gemcitabine hydrochloride, cisplatin, and AGS-003-BLD work in treating patients with bladder cancer that has spread to the muscle and who are undergoing surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells. Giving gemcitabine hydrochloride, cisplatin, and AGS-003-BLD before surgery may make the tumor smaller and reduce the amount of tissue that needs to be removed by surgery.

Detailed description

PRIMARY OBJECTIVES: I. To assess the immunogenicity of AGS-003-BLD in subjects with muscle invasive bladder cancer. SECONDARY OBJECTIVES: I. To assess 1-year disease-free survival rate of patients with muscle-invasive bladder cancer who receive cisplatin/gemcitabine chemotherapy plus AGS-003-BLD. II. To determine the time to first metastatic lesion. III. To explore the disease-free and overall survival of patients treated with this treatment combination. IV. To evaluate the pathologic complete response (pCR) rate and identify any activity of this treatment combination. V. To evaluate toxicities and tolerability associated with this treatment combination. VI. To assess the success rate of tumor procurement and AGS-003-BLD production of \>= 5 doses. TERTIARY OBJECTIVES: I. To evaluate the relationships between pathologic complete response with the change in CD28+ T cell levels. II. To evaluate the change in frequency of CD11a highPD-1+ CD8+ T cells (and their expression of Bim) in peripheral blood. OUTLINE: NEOADJUVANT PHASE: Patients receive gemcitabine hydrochloride intravenously (IV) on days 1 and 8, AGS-003-BLD intradermally (ID) on day 1, and cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive AGS-003-BLD ID on day 1. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo cystectomy during course 8. ADJUVANT PHASE: Patients continue AGS-003-BLD ID on day 1 of course 9. Treatment repeats every 12 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years.

Conditions

• Infiltrating Bladder Urothelial Carcinoma
• Stage II Bladder Urothelial Carcinoma
• Stage III Bladder Urothelial Carcinoma
• Stage IV Bladder Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin	Given IV
DRUG	Gemcitabine Hydrochloride	Given IV
PROCEDURE	Radical Cystectomy	Undergo cystectomy
BIOLOGICAL	Tumor Cell-Derived Vaccine Therapy	Given AGS-003-BLD ID

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-09-05
• Completion: 2017-09-05
• First posted: 2016-10-25
• Last updated: 2017-11-17

Locations

1 site across 1 country: United States