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Gene Therapy
Gene Therapy for Ovarian and Related Cancers
Phase 2
Waitlist Available
Research Sponsored by John Stoddard Cancer Center at Iowa Methodist Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cardiovascular: No cardiac dysfunction by history and exam, No ischemic heart disease that may be considered anesthetic or operative risk
Must have failed standard therapy with both a platinum agent (cisplatin or carboplatin) and paclitaxel
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test if gene therapy can help kill cancer cells in women with ovarian, fallopian tube, or peritoneal cancer that has not responded to other treatments or has come back.
Who is the study for?
This trial is for women over 18 with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer that's come back or didn't respond to treatment. They must have tried a platinum agent and paclitaxel without success. Their disease should be small (under 5 cm), visible on scans or exam, and they need enough tumor tissue for testing. Participants require decent blood counts, liver and kidney function, no serious heart or lung conditions, not pregnant/nursing, HIV negative, and no recent infections.Check my eligibility
What is being tested?
The study is looking at gene therapy as a way to boost the immune system to fight cancer in women whose ovarian-related cancers are resistant to standard treatments. It's a Phase II trial which means it focuses on the effectiveness of this new approach after initial safety has been assessed.See study design
What are the potential side effects?
While specific side effects aren't listed here, gene therapy can sometimes cause flu-like symptoms such as fever and chills; pain at injection site; fatigue; headache; nausea; muscle ache; allergic reactions including anaphylaxis may also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart is healthy and I have no history of heart disease.
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My cancer did not respond to treatments with cisplatin or carboplatin and paclitaxel.
Select...
I am 18 years old or older.
Select...
I am able to get out of my bed or chair and move around.
Select...
My ovarian, fallopian tube, or peritoneal cancer has returned or didn't respond to treatment.
Select...
My disease can be measured or seen on a CT scan, by physical exam, or through laparoscopy.
Select...
My liver functions are within the required limits and I don't have hepatitis B.
Select...
My kidney function is normal, with creatinine levels at or below 2.0 mg/dL or clearance above 50 mL/min.
Select...
My cancer is smaller than 5 cm at its largest point.
Select...
I have a tissue sample from my tumor available for testing.
Select...
I do not have more than 2 liters of fluid in my abdomen.
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?
John Stoddard Cancer Center at Iowa Methodist Medical CenterLead Sponsor
Charles Joseph Link, MDStudy ChairJohn Stoddard Cancer Center at Iowa Methodist Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart is healthy and I have no history of heart disease.I have no history of heart problems.I do not have heart disease that increases surgery risk.I do not have lung conditions that increase surgery risks.My cancer did not respond to treatments with cisplatin or carboplatin and paclitaxel.My ovarian, fallopian tube, or peritoneal cancer has returned or didn't respond to treatment.My liver functions are within the required limits and I don't have hepatitis B.I am 18 years old or older.I am able to get out of my bed or chair and move around.My disease can be measured or seen on a CT scan, by physical exam, or through laparoscopy.My kidney function is normal, with creatinine levels at or below 2.0 mg/dL or clearance above 50 mL/min.My cancer is smaller than 5 cm at its largest point.I haven't taken medication for an infection in the last 14 days.I have had surgery to remove internal scar tissue.I don't have severe scarring in my abdomen from disease or surgery.I have a tissue sample from my tumor available for testing.I do not have lung conditions that increase surgery risks.I am not taking high doses of vitamins.I do not have more than 2 liters of fluid in my abdomen.
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.
Are there any open slots in this experiment currently available?
"According to clinicaltrials.gov, this investigation is no longer recruiting patients; the study was initially posted on June 1st 2000 and last updated November 5th 2013. However, 690 other studies are currently seeking volunteers for their research."
Answered by AI
What risks are associated with this course of treatment?
"Our internal assessment of this therapy's safety is a 2, as it has been through Phase 2 trials and there are some validations on its security though no evidence yet confirming efficacy."
Answered by AI
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