Your session is about to expire
← Back to Search
Virus Therapy
Gene Therapy vs Chemotherapy for Head and Neck Cancer
Phase 3
Waitlist Available
Research Sponsored by Introgen Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have had radiation and chemotherapy treatments
Must be 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will compare the effectiveness of a gene therapy that inserts the p53 gene into cancer cells with the chemotherapy drug methotrexate in patients with recurrent head and neck cancer.
Who is the study for?
This trial is for adults over 18 with recurrent squamous cell cancer of the head and neck (SCCHN) who have already tried radiation and chemotherapy. It's not suitable for those eligible for surgery or who've had methotrexate treatments before.Check my eligibility
What is being tested?
The study compares a new gene therapy called INGN 201, which introduces a modified p53 gene to tumor cells, against methotrexate in patients whose SCCHN has resisted standard treatments like surgery, radiotherapy, and certain chemotherapies.See study design
What are the potential side effects?
Potential side effects may include typical reactions to gene therapy such as fever, chills, nausea, pain at injection site or allergic reactions. Methotrexate can cause mouth sores, low blood counts, nausea and liver problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have undergone both radiation and chemotherapy treatments.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Find a Location
Who is running the clinical trial?
Introgen TherapeuticsLead Sponsor
4 Previous Clinical Trials
85 Total Patients Enrolled
Kerstin Menander, MDStudy Director
1 Previous Clinical Trials
Julie L Sicam, MT (ASCP) MSHSStudy Chair
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never been treated with methotrexate.I have undergone both radiation and chemotherapy treatments.I cannot have surgery for my condition.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Does this treatment come with a high risk of patient harm?
"This medical treatment is considered to be relatively safe, as it has reached Phase 3 in clinical trials. This means that there is some evidence supporting its efficacy, as well as multiple rounds of data confirming its safety."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger