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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

Must not have

Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency are not eligible. Patients at risk for G6PD deficiency must be screened prior to enrollment

Patients who have known brain metastases, as they are not candidates for surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6-8 hours post-triapine infusion

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have G6PD deficiency.

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I have brain metastases and cannot undergo surgery.

Timeline

Screening ~ 3 weeks3 visits

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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 5 minutes before end of triapine infusion, 6-8 hours post-infusion (at time of surgical tissue resection), and 24 hours post-infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pharmacodynamic response

Secondary study objectives

Incidence of adverse events

Pharmacokinetic (PK) analysis

Other study objectives

Single-cell transcriptome analysis

Whole exome sequencing (WES) analysis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1150

Biospecimen Collection

2004

Completed Phase 3

~2030