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Gene Therapy
Gene Therapy for Head and Neck Cancer
Phase 2
Waitlist Available
Research Sponsored by Aventis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recurrent disease documented by histology or cytology (excluding endolaryngeal recurrence) following first line therapy with curative intent, such as: Radiation (at least 5000 cGy by standard methodology) and/or Surgery (definitive resection with postoperative radiation as indicated)
Performance status: Karnofsky 60-100%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test whether inserting the gene for p53 into a person's tumor can improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy.
Who is the study for?
This trial is for adults with recurrent squamous cell carcinoma of the head and neck, who have tried at least one treatment like radiation or surgery. Their cancer must be measurable, not spread to the brain, and they should have a sample available for genetic testing. They need to be generally healthy with no severe infections or other cancers in the last two years.Check my eligibility
What is being tested?
The study is testing gene therapy that involves inserting a p53 gene into tumors. The goal is to see if this can make the body better at fighting cancer or make the cancer more responsive to chemotherapy.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions related to gene therapy such as immune responses, inflammation at injection sites, fever, fatigue, muscle aches and potential risks associated with altering DNA within cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer came back after treatments like surgery or radiation aimed at curing it.
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I can care for myself but may not be able to do active work.
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I am 18 years old or older.
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My cancer is a type of squamous cell carcinoma located in the head or neck.
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My cancer came back after initial treatments aimed at curing it, such as surgery or radiation.
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My cancer can be reached for direct injections.
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My cancer has not spread to my brain.
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My liver function tests are within normal limits.
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?
Aventis PharmaceuticalsLead Sponsor
80 Previous Clinical Trials
16,742 Total Patients Enrolled
Lyndah Dreiling, MDStudy ChairAventis Pharmaceuticals
5 Previous Clinical Trials
894 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer came back after treatments like surgery or radiation aimed at curing it.I am not planning any surgery on the areas where the study drug will be injected.I am not on high dose steroids, haven't had experimental therapy in 4 weeks, and have never had gene therapy with adenoviral vectors.I can care for myself but may not be able to do active work.I am 18 years old or older.My cancer is a type of squamous cell carcinoma located in the head or neck.My kidney function is not specified for this trial.I am not on immune-boosting drugs and haven't had an organ or tissue transplant.It's been over 4 weeks since my last chemotherapy, and over 6 weeks if it was with nitrosourea or mitomycin. I'm not on any other chemotherapy.I am not taking high doses of steroids, except for low-dose long-term use.I haven't had radiotherapy on my cancer sites for at least 4 weeks.My cancer came back after initial treatments aimed at curing it, such as surgery or radiation.My cancer can be reached for direct injections.My cancer has not spread to my brain.My tumor biopsy is available for p53 mutation testing.My liver function tests are within normal limits.
Research Study Groups:
This trial has the following groups: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.
Has this therapeutic intervention been sanctioned by the appropriate regulatory authority?
"Based on our assessment, this treatment has been given a score of 2. This is because the trial is currently in Phase 2 and there exists some evidence to support its safety but no proof yet of efficacy."
Answered by AI
Are there any open enrollment opportunities for this research endeavor?
"Clinicaltrials.gov states that recruitment for this clinical trial has ceased as of December 3, 2013; the initial post date being January 1, 1998. Despite its inactive status, there are 481 other studies currently recruiting patients to participate."
Answered by AI
In which locales is this investigation being conducted?
"Those interested in the trial can find 10 participating sites, such as Simmons Cancer Center - Dallas in Dallas, University of Iowa Hospitals and Clinics in Iowa City, Tulane University School of Medicinein New Orleans and other locations around America."
Answered by AI
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