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Monoclonal Antibodies
ATRA + Atezolizumab for Lung Cancer
Phase 1
Recruiting
Led By Dwight H Owen, MD
Research Sponsored by Dwight Owen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is to find out the best dose and side effects of ATRA and atezolizumab for treating patients with non-small cell lung cancer that has come back or has spread.
Who is the study for?
This trial is for adults with recurrent or metastatic non-small cell lung cancer who have tried standard treatments. They must be able to take oral medication, not have curable cancer options left, and agree to use birth control. People with certain health conditions, active autoimmune diseases, or untreated brain metastases can't join.Check my eligibility
What is being tested?
The trial tests the combination of ATRA (a vitamin A derivative) and atezolizumab (an immunotherapy drug) to find the best dose and monitor side effects in patients whose lung cancer has returned or spread.See study design
What are the potential side effects?
Possible side effects include immune system reactions that may affect organs, infusion-related reactions from atezolizumab, fatigue, digestive issues like nausea or diarrhea from ATRA, as well as potential blood abnormalities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am able to care for myself and perform daily activities.
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I can swallow and keep down pills.
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My lung cancer has returned or spread and cannot be cured.
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I had hepatitis C but have been treated and cured.
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 adverse events (AEs)
Secondary outcome measures
Disease control rate
Overall response
Overall survival (OS)
+1 moreOther outcome measures
Effect of ATRA on the levels of myeloid-derived suppressor cells (MDSCs)
Side effects data
From 2009 Phase 4 trial • 163 Patients • NCT0083519810%
Cold
5%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tretinoin Gel 0.025%
Dapsone Gel 5% and Tretinoin Gel 0.025%
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tretinoin, atezolizumab)Experimental Treatment2 Interventions
Patients receive tretinoin PO on days 1-3 of cycles 1-3. Patients also receive atezolizumab IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Tretinoin
2013
Completed Phase 4
~2040
Find a Location
Who is running the clinical trial?
Dwight OwenLead Sponsor
4 Previous Clinical Trials
171 Total Patients Enrolled
Dwight H Owen, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
Dwight H Owen, MD, MS, FACPPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using two birth control methods or am not having sex to avoid pregnancy during and 5 months after the study.I agree to use contraception and not donate sperm for 7 months after my last treatment dose.I have severe liver disease with complications like confusion or fluid in my abdomen.I agree to use birth control during and for 4 months after the study.I have received all approved treatments for my specific cancer mutation.Your blood and body chemistry should be within certain normal levels.I have undergone standard chemotherapy or immunotherapy for my condition.You are expected to live for at least 3 more months.I have treated brain metastases and have been stable without steroids for at least 2 weeks.I have an autoimmune disease treated with strong medication in the last 2 years.Your disease can be measured using a specific set of guidelines called RECIST 1.1.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I am 18 years old or older.I had severe side effects from previous immunotherapy.I am able to care for myself and perform daily activities.I can swallow and keep down pills.I have had side effects in my brain, eyes, or heart from immunotherapy.My lung cancer has returned or spread and cannot be cured.I am HIV-positive, on treatment, and my viral load is undetectable.I had hepatitis C but have been treated and cured.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tretinoin, atezolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical ailments is Tretinoin most frequently prescribed to treat?
"Tretinoin is approved for the management of small cell lung cancer, as well as malignant tumours and certain dermatological issues such as cystic acne. It may also be used to treat keratinization disorders on feet."
Answered by AI
Can you detail any former experiments that have examined the use of Tretinoin?
"At present, Tretinoin is being studied in 376 live clinical studies with 75 of those trials currently in Phase 3. With the majority of these investigations taking place within New york City, there are 18656 sites running experiments related to this medication."
Answered by AI
Could Tretinoin pose a risk to individuals' wellbeing?
"Our assessment of Tretinoin's safety is a 1 - as this is a Phase I trial, there is not much data attesting to its efficacy and limited information verifying its security."
Answered by AI
Are there still vacancies available in this research project?
"Affirmative. Clinicaltrials.gov displays that this clinical trial is currently recruiting participants, having first been posted on October 18th 2021 and recently modified on April 27th 2022."
Answered by AI
What is the upper limit for participants in this trial?
"Affirmative. Clinicaltrials.gov provides evidence that this research, first published on October 18th 2021, is currently recruiting participants. There are openings for eighteen patients at one medical facility."
Answered by AI
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