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Topoisomerase I inhibitor

Irinotecan for Sarcoma

Phase 2
Waitlist Available
Research Sponsored by Herbert Irving Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Bidimensionally measurable disease on x-ray, MRI or CT scan, or physical exam (outside of previously irradiated area)
Creatinine less than ULN OR Creatinine clearance greater than 60 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying how well irinotecan works in treating patients with stage IV or recurrent soft tissue sarcoma that has been previously treated with chemotherapy.

Who is the study for?
This trial is for adults with advanced soft tissue sarcoma that has returned or spread, and who have tried but didn't respond well to up to two chemotherapy treatments, including one with doxorubicin. They must have measurable tumor growth outside of previously treated areas and no cancer spread to the brain.Check my eligibility
What is being tested?
The study is testing the effectiveness of a chemotherapy drug called Irinotecan in patients with stage IV or recurrent soft tissue sarcoma. It's specifically for those whose disease progressed after previous chemotherapy treatments.See study design
What are the potential side effects?
Irinotecan can cause side effects like diarrhea, fatigue, hair loss, nausea, vomiting, low white blood cell count (increasing infection risk), anemia (low red blood cells), and decreased appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured on scans or physical exams.
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My kidney function is normal or above 60 mL/min.
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I do not have heart failure that needs treatment.
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I do not have Gilbert's syndrome.
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I've had 1-2 chemotherapy treatments, one with doxorubicin, for my cancer.
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I am 18 years old or older.
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My sarcoma is advanced and cannot be removed with surgery.
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My cancer has not spread to my brain.
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I do not have any ongoing or untreated infections.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I have not had a heart attack in the last 6 months.
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I do not have any physical, mental, or emotional health issues.

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

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Who is running the clinical trial?

Herbert Irving Comprehensive Cancer CenterLead Sponsor
33 Previous Clinical Trials
902 Total Patients Enrolled
4 Trials studying Sarcoma
25 Patients Enrolled for Sarcoma
Robert N. Taub, MD, PhDStudy ChairHerbert Irving Comprehensive Cancer Center
6 Previous Clinical Trials
82 Total Patients Enrolled
4 Trials studying Sarcoma
25 Patients Enrolled for Sarcoma

Media Library

Irinotecan (Topoisomerase I inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00003719 — Phase 2
Sarcoma Research Study Groups:
Sarcoma Clinical Trial 2023: Irinotecan Highlights & Side Effects. Trial Name: NCT00003719 — Phase 2
Irinotecan (Topoisomerase I inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003719 — 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 for volunteers in this research project?

"No, this study is not presently recruiting patients according to the information found on clinicaltrials.gov. This particular trial was posted on 7/1/1997 and was last edited on 1/3/2014; however, there are other trials that may be of interest as they are actively enrolling participants."

Answered by AI

Is this medication cleared by the FDA?

"While there is some evidence from Phase 2 trials to support the safety of this treatment, it has not been proven effective. Therefore, our team at Power estimates the safety of this treatment to be a 2."

Answered by AI
~1 spots leftby Mar 2025