Mechanism of Action Trial of ColoAd1 (NCT02053220) | Clinical Trial Compass
CompletedPhase 1
Mechanism of Action Trial of ColoAd1
Spain17 participantsStarted 2013-06
Plain-language summary
To assess the pattern of ColoAd1 viral delivery and viral expression within colon tumour tissue when administered by intra-tumoural injection or within colon, non-small cell lung, bladder and renal cell tumour tissues following ColoAd1 administration by intravenous infusion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
Patients must meet all the following criteria to be eligible for participation:
* Able and willing to provide written informed consent and to comply with the study protocol
* Age ≥ 18 years
* Patients with histologically confirmed resectable colon cancer, NSCLC (squamous and non-squamous), bladder cancer (urothelial cell carcinoma) or RCC (renal cell carcinoma), scheduled for resection of primary tumour and with planned resection of draining lymph nodes for colon cancer
* Diagnostic colonoscopy performed at the study centre (Cohorts A and B only) or a referral centre (Cohort B only) and a report from this colonoscopy available for the study
* Tumour size of 3 cm or more in diameter as estimated during diagnostic colonoscopy for cohorts A and B or by CT-scan for cohorts C, D and E.
* At least 2 weeks since the last dose of any intravenous systemic chemotherapy at time of first administration of ColoAd1
* Recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies.
* Able to undergo surgery with general anaesthesia
* Surgery planned and administration of ColoAd1 feasible within
* 15 days of planned surgery (following IT administration or following first dose of IV administration) for cohorts A and B
* 10 - 25 days of first ColoAd1 administration for cohorts C, D and E
* ECOG Performance Status Score of 0 or 1
* Adequate renal function
* Creatinine ≤ 1.5 mg/dL or calculated creatinine clearance using the Co…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.