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Virus Therapy
CG0070 for Bladder Cancer
Phase 1
Recruiting
Led By Roger Li, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Have all visible disease except a single 'marker lesion' of approximately 0.3 - 1 cm diameter removed at baseline prior to initial CG0070 treatment (photographic documentation of lesion location and size must be conducted)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will assess how safe CG0070 is as a treatment for patients with a certain type of bladder cancer called Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC).
What is being tested?
This trial is focused on assessing the safety of a treatment called CG0070 for patients with Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC).See study design
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
All my visible cancer, except one small area, has been removed before starting CG0070 treatment.
Select...
My blood tests show my organs are functioning well.
Select...
My bladder cancer is confirmed to be a specific type and stage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
12-month recurrence free survival rate (RFS)
24-month recurrence free survival rate (RFS)
Complete Response Rate (CR)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CG0070Experimental Treatment1 Intervention
CG0070 is a conditionally replicating oncolytic adenovirus (serotype 5) designed to preferentially replicate in and kill cancer cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CG0070
2015
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
548 Previous Clinical Trials
135,608 Total Patients Enrolled
Roger Li, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
21 Total Patients Enrolled
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