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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 below
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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.
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I am 18 years old or older.
Select...
I am able to get out of my bed or chair and move around.
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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.
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My cancer is smaller than 5 cm at its largest point.
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I have a tissue sample from my tumor available for testing.
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I do not have more than 2 liters of fluid in my abdomen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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

Gene Therapy (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00005025 — Phase 2
Ovarian Cancer Research Study Groups:
Ovarian Cancer Clinical Trial 2023: Gene Therapy Highlights & Side Effects. Trial Name: NCT00005025 — Phase 2
Gene Therapy (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00005025 — Phase 2

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
~14 spots leftby Mar 2025