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Triapine for Uterine Cancer

Q: 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.

Q: 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 <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> 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.

Q: 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.

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

Research into triapine began in 2016 at Medical <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> and Hematology Associates-Laurel, leading to 65 completed trials. Currently, 4 active studies are being conducted across Miami, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a>.

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.

Select...

I can understand and am willing to sign the consent form.

Select...

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.

Select...

I am scheduled for a surgical removal of the uterus and staging.

Select...

My hepatitis B is under control with treatment.

Select...

My tumor is large enough for both research and clinical tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-triapine infusion, surgical resection

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

~1730

Resection

2021

Completed Phase 2

~410

Triapine

2006

Completed Phase 1

~30

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,663 Previous Clinical Trials

40,925,893 Total Patients Enrolled

18 Trials studying Endometrial Carcinoma

8,838 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

Recent research and studies

clinicaltrials.govStudy

Testing the Response to the Anti-cancer Drug, Triapine, in Uterine Cancers Using Markers From the Tissue at the Time of Hysterectomy

2022. "Testing the Response to the Anti-cancer Drug, Triapine, in Uterine Cancers Using Markers From the Tissue at the Time of Hysterectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04494113.

All > Uterine Cancer