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Alkylating agents
Anti-Cancer Viral Therapy + Chemoradiation for Esophageal Cancer
Phase 1
Recruiting
Led By Geoffrey Y Ku
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception
Gastroesophageal junction tumors must be Siewert type I/II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a virus that is designed to infect and destroy tumor cells in patients with esophageal or gastroesophageal cancer. The virus will be given with chemotherapy drugs and radiation therapy.
Who is the study for?
This trial is for adults with advanced esophageal or gastroesophageal cancer who can't have surgery. They must be in good physical condition, not pregnant, and willing to use contraception. People with other cancers that won't affect this study can join too. But those with certain infections, previous treatments for their cancer, or serious health issues like uncontrolled diabetes cannot participate.Check my eligibility
What is being tested?
The trial tests Telomelysin™ (OBP-301), a virus targeting cancer cells, combined with chemotherapy drugs carboplatin and paclitaxel plus radiation therapy. The goal is to see if this mix works better than the usual chemo and radiation for these types of cancer.See study design
What are the potential side effects?
Possible side effects include normal cell infection by OBP-301, typical chemotherapy-related issues like nausea and hair loss, as well as skin irritation from radiation. There's also a risk of more severe reactions due to the body's response to the viral therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and agree to use birth control.
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My tumor at the stomach and esophagus junction is a specific type (Siewert I or II).
Select...
I am HIV positive, on treatment, and my viral load is undetectable.
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I cannot have surgery but can undergo chemoradiation.
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My tumor can be treated with direct injections and I can undergo 3 endoscopies.
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
Dose Limiting Toxicity
Secondary outcome measures
Clinical Complete Response (cCR)
Incidence of Adverse Events
Overall Survival
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (OBP-301, carboplatin, paclitaxel, radiation)Experimental Treatment4 Interventions
Patients receive OBP-301 by intratumoral injection on days -3, 12, and 26. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 60 minutes on days 1, 8, 15, 22, and 29, and undergo radiation therapy on Monday through Friday beginning day 1 for 28 fractions over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,836 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,838 Total Patients Enrolled
Geoffrey Y KuPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have uncontrolled diabetes or an active infection needing IV antibiotics.I have another cancer that does not affect this treatment's safety or effectiveness.I have a history of heart disease.I am not pregnant and agree to use birth control.I have completed all required tests for my lung cancer diagnosis.My cancer has spread to nearby structures.I have not recently received a live vaccine or blood transfusion.I am currently breastfeeding.My cancer has spread to other parts of my body.I was diagnosed with esophagus or gastroesophageal junction cancer in the last 90 days.My tumor at the stomach and esophagus junction is a specific type (Siewert I or II).I have had chemotherapy or radiotherapy for my cancer before.I am HIV positive, on treatment, and my viral load is undetectable.I have chronic hepatitis B or C and meet specific health criteria.I haven't taken immunosuppressive drugs in the last week.I cannot have surgery but can undergo chemoradiation.My tumor can be treated with direct injections and I can undergo 3 endoscopies.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (OBP-301, carboplatin, paclitaxel, radiation)
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.
Is it possible to join the experiment at this point in time?
"Affirmative. Clinicaltrials.gov reveals that this trial, initially listed on June 29th 2020 and last updated November 22nd 2022, is currently seeking enrolment of 21 participants across 3 sites."
Answered by AI
Are there any documented hazards associated with Radiation Therapy?
"As this is an early-phase trial with limited data supporting the efficacy and safety of Radiation Therapy, our team at Power assigned it a score of 1."
Answered by AI
How many individuals are eligible for enrollment in this medical research?
"Affirmative. Evidence hosted on clinicaltrials.gov corroborates that this medical experiment, which was first posted on June 29th 2020, is actively recruiting participants. Approximately 21 patients need to be enrolled from 3 separate study sites."
Answered by AI
Are there any other clinical trials that have evaluated the efficacy of Radiation Therapy?
"In 1997, City of Hope Comprehensive Cancer Center first evaluated the use of Radiation Therapy in clinical trials. Since then, 1646 studies have been concluded and 1174 are still recruiting participants. Notably, many of these active studies originate from Duarte, California."
Answered by AI
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