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Meeting Goals and
Objectives:
 To
foster the development of cutting edge clinical trials
To highlight
the most critical questions for clinical or translational research
To identify
new clinical research opportunities
To identify
existing barriers to needed research
To consider
improvements in clinical trial designs
Discussion Points:
Markers
for detection, prognosis, risk stratification, prediction & monitoring
of response to therapy, prediction of invasion/progression
Multiplicity
of markers and relevant biologic pathways
High
throughput technologies in genomics and proteomics
Statistical
& trial design issues
Potential
use as surrogate endpoints
Prioritization
Identification
of candidate markers that can serve multiple roles
"Marker
tumors": following tumors in situ to evaluate response
Risk
stratification
Definitions
for risk groups
Review
of selected stage and grade determination schemes
Accurate
classification of individuals
Biology
of tumor recurrence and progression
Strategies
for applying developments of different technologies
Effectiveness
and limitations of intravesical therapy
Possible
new methods for effective delivery
New targets
& strategies for development of targeted therapies
New chemoprevention
agents
Key Recommendations:
Coordinated
support for marker evaluation & validation
Support
for tumor (and urine) banking, with appropriate quality control
Further
evaluation and use of promising bladder cancer models
Risk
stratification and sequential (cascading) trial designs for various clinical
presentations
Combined
modality interventions to simultaneously address macroablation of initial
tumor(s), reimplantation, subclinical residual disease,
and new primary tumors (chemoprevention)
Prospective
studies to test lower intensity surveillance for selected groups of patients
Optimization
of therapeutics administration, including use of modeling
Further
exploration of promising results with peri-op chemotherapy
Evaluation
of host response to therapies, particularly immunotherapy
Exploration
of new delivery strategies for therapeutics
Further
explore the question of, and evidence for, a field defect
In addition
to established clinical trials networks (especially for larger phase III
trials), there would be value to having coordinated
focus groups and networks for bladder cancer in the
public sector, particularly for phase I/II trials
Future
meetings are needed for ongoing discussion of new directions
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