Gemcitabine Hydrochloride, Cisplatin, and AGS-003-BLD in Treating Patients With Muscle-Invasive Bladder Cancer Undergoing Surgery
NCT ID: NCT02944357
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2016-11-30
2017-09-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment (gemcitabine hydrochloride, cisplatin, AGS-003-BLD)
NEOADJUVANT PHASE: Patients receive gemcitabine hydrochloride IV on days 1 and 8, AGS-003-BLD 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.
Cisplatin
Given IV
Gemcitabine Hydrochloride
Given IV
Radical Cystectomy
Undergo cystectomy
Tumor Cell-Derived Vaccine Therapy
Given AGS-003-BLD ID
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cisplatin
Given IV
Gemcitabine Hydrochloride
Given IV
Radical Cystectomy
Undergo cystectomy
Tumor Cell-Derived Vaccine Therapy
Given AGS-003-BLD ID
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Verification received from Argos Therapeutics that ribonucleic acid (RNA) successfully collected from TURBT procedure
* Be a candidate for radical cystectomy
* Diagnosis of urothelial carcinoma with stage T2 or greater disease without lymph node involvement where neoadjuvant chemotherapy of cisplatin and gemcitabine are indicated
* Absolute neutrophil count (ANC) \>= 1500/uL
* Platelet count \>= 100,000/uL
* Total bilirubin =\< 1.5 x institutional upper normal limit (UNL) or =\< 3 x institutional UNL if known Gilbert's syndrome
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x UNL
* Alkaline phosphatase =\< 5 x UNL
* Hemoglobin \>= 9.0 g/dL
* International normalized ratio (INR) and partial thromboplastin time (PTT) =\< 3.0 x UNL; NOTE: anticoagulation is allowed if target INR =\< 3.0 x UNL on a stable dose of warfarin or on a stable dose of low molecular weight heparin for \> 2 weeks at time of registration
* Calculated creatinine clearance must be \>= 50 ml/min using the applicable Cockcroft-Gault formula
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Ability to provide written informed consent
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
* Willing to provide tissue and blood samples for correlative research purposes
* Negative serum pregnancy test for female subjects with reproductive potential =\< 7 days prior to registration, for women of childbearing potential only
* Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study
Exclusion Criteria
* Known inability to undergo neoadjuvant gemcitabine and cisplatin combination treatment due to pre-existing medical conditions in the opinion of the treating physician or investigator
* Immunotherapy =\< 28 days prior to pre-registration (e.g. intravesical Bacillus Calmette-Guerin \[BCG\])
* Any of the following prior therapies:
* Systemic chemotherapy for bladder cancer at any time; NOTE: intravesical chemotherapy is allowed
* Systemic chemotherapy for other malignancies =\< 3 years prior to pre-registration
* Lymph node positive urothelial carcinoma
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator
* Treatment with oral/systemic corticosteroids =\< 14 days prior to registration, with the exception of topical or inhaled steroids or steroids given for the purpose of antiemetics during chemotherapy
* New York Heart Association classification III or IV congestive heart failure
* Central nervous system (CNS) metastases or seizure disorder
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation) with the exception of intravesical therapy at the time of TURBT
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Clinically significant infections including human immunodeficiency virus (HIV), syphilis, and active hepatitis B or C
* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
* Prior history of malignancy =\< 3 years prior to registration, except for adequately treated non-melanoma skin cancer, adequately treated early stage breast cancer, adequately treated cervical cancer and non-metastatic prostate cancer under clinical control as deemed by treating physician or investigator
* History of myocardial infarction =\< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
* History of major surgery or traumatic injury =\< 28 days prior to registration or other major anticipated procedures requiring general anesthesia during study participation
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brian Costello
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2016-01517
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC1452
Identifier Type: OTHER
Identifier Source: secondary_id
MC1452
Identifier Type: -
Identifier Source: org_study_id