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Triapine for Uterine Cancer

Phase < 1
Recruiting
Led By Rebecca L Stone
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must not have received any prior anticancer treatment for endometrial cancer
Patients must have histologically confirmed uterine corpus serous adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 5 minutes before end of triapine infusion, 6-8 hours post-infusion (at time of surgical tissue resection), and 24 hours post-infusion
Awards & highlights

Study Summary

This trial is testing the anti-cancer drug triapine in women with uterine cancer. It will use markers from tissue samples to see if the drug stops the growth of tumor cells.

Who is the study for?
This trial is for adults with specific types of uterine cancer who are planning to have a hysterectomy and haven't had previous cancer treatment. They must be in good health overall, with proper kidney, liver, and blood cell function. People with certain heart conditions or infections like hepatitis B or C need to have them under control. Pregnant women can't join, and participants should understand the study well enough to consent.Check my eligibility
What is being tested?
The trial is testing Triapine's effectiveness when added to standard surgery followed by chemotherapy or radiation therapy for uterine cancers. Researchers will look at tissue markers from samples collected during surgery to see how the tumor cells respond.See study design
What are the potential side effects?
Triapine may cause side effects such as blocking enzymes needed for cell growth which could affect normal cells too leading to potential fatigue, digestive issues, changes in blood counts affecting immunity and healing, as well as possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had any previous cancer treatment for endometrial cancer.
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My cancer is a specific type of uterine cancer called serous adenocarcinoma.
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I can take care of myself but might not be able to do heavy physical work.
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I can understand and am willing to sign the consent form.
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I am 18 years old or older.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I am scheduled for a surgical removal of the uterus and staging.
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My hepatitis B is under control with treatment.
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My tumor is large enough for both research and clinical tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-triapine infusion, surgical resection
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-triapine infusion, surgical resection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacodynamic response
Secondary outcome measures
Incidence of adverse events
Pharmacokinetic (PK) analysis
Other outcome measures
Single-cell transcriptome analysis
Whole exome sequencing (WES) analysis

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (triapine, surgical resection)Experimental Treatment4 Interventions
Patients receive triapine IV over 2 hours on day 1. Patients then undergo surgical resection and tissue collection 6-8 hours after the initiation of the triapine infusion. Patients also undergo biopsy and collection of blood samples on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720
Resection
2023
Completed Phase 2
~420
Triapine
2006
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,715 Previous Clinical Trials
40,953,825 Total Patients Enrolled
17 Trials studying Endometrial Carcinoma
8,748 Patients Enrolled for Endometrial Carcinoma
Rebecca L StonePrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO

Media Library

Triapine Clinical Trial Eligibility Overview. Trial Name: NCT04494113 — Phase < 1
Endometrial Carcinoma Research Study Groups: Treatment (triapine, surgical resection)
Endometrial Carcinoma Clinical Trial 2023: Triapine Highlights & Side Effects. Trial Name: NCT04494113 — Phase < 1
Triapine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04494113 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participation levels of this investigation?

"Affirmative. Information on clinicaltrials.gov suggests that this research study, initially published on November 11th 2020, is still recruiting volunteers. 12 individuals are needed from 6 different medical facilities to complete the trial."

Answered by AI

What is the geographic distribution of sites participating in this trial?

"Six medical centres in total are participating in the trial, including University of Miami Miller School of Medicine-Sylvester Cancer Center, UM Sylvester Comprehensive Cancer Center at Deerfield Beach and UM Sylvester Comprehensive Cancer Center at Plantation. Additionally, other three sites can be found throughout the country."

Answered by AI

Is there still room for participation in this research endeavor?

"Indeed, the clinicaltrials.gov database conveys that this experiment is presently recruiting participants. It was initially publicized on November 11th 2020 and its entry was last revised on November 30th 2022. A total of 12 individuals from 6 distinct sites need to be recruited for it."

Answered by AI

Are there any precedent trials utilizing Triapine that have been conducted?

"Research into triapine began in 2016 at Medical Oncology and Hematology Associates-Laurel, leading to 65 completed trials. Currently, 4 active studies are being conducted across Miami, Florida."

Answered by AI
~2 spots leftby Nov 2024