Study on the Effectiveness of Triapine with Radiation Treatment Compared to Radiation Alone for Metastatic Neuroendocrine Tumors

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05724108

Provider View

This clinical trial is testing whether adding the drug Triapine to a standard radiation treatment, Lutetium Lu 177 Dotatate, can better shrink or slow the growth of neuroendocrine tumors that have spread in the body, compared to using the radiation treatment alone.

Patient Parameters

Program Overview

The purpose of this study is to see if combining the drug Triapine with the radiation treatment Lutetium Lu 177 Dotatate is more effective at shrinking or slowing the growth of neuroendocrine tumors that have spread to other parts of the body. Triapine may help stop tumor growth by blocking certain enzymes needed for DNA and cell growth. Lutetium Lu 177 Dotatate is a radioactive drug that targets a protein on some tumor cells, delivering radiation to kill them. This study will compare the effects of the combination treatment to the standard radiation treatment alone.

Description

The study has two main goals: to compare how well the combination of Triapine and Lutetium Lu 177 Dotatate works against tumors compared to Lutetium Lu 177 Dotatate alone, and to see how long patients live without the cancer getting worse.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will receive Triapine by mouth for 14 days and Lutetium Lu 177 Dotatate through an IV on the first day of each 8-week cycle, for up to 4 cycles. They will also have regular scans and blood tests.
  • Group 2: Will receive Lutetium Lu 177 Dotatate through an IV on the first day of each 8-week cycle, for up to 4 cycles. They will also have regular scans and blood tests.

After finishing the treatment, participants will have follow-up visits at 8 and 12 months, and then every 6 months for 2 years.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of metastatic neuroendocrine tumor with a positive scan.
  • The cancer must be growing, as shown by recent scans.
  • Have measurable disease according to specific criteria.
  • Have tried at least one other cancer treatment that didn't work.
  • No previous treatment with similar radiation therapy.
  • Must have recovered from side effects of past treatments.
  • Be 18 years or older.
  • Be in good general health with a performance status of 0 to 2.
  • Have adequate blood counts and organ function.
  • HIV-positive patients must have an undetectable viral load.
  • Hepatitis B and C patients must have controlled or cured infections.
  • Patients with stable brain metastases can participate.
  • Must not have other health conditions that interfere with the study.
  • Women and men must use effective birth control during and after the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Have not fully recovered from side effects of previous treatments.
  • Are taking other experimental drugs.
  • Have allergies to similar drugs.
  • Have uncontrolled health issues.
  • Have severe heart failure.
  • Are pregnant or breastfeeding.
  • Cannot swallow pills or have digestive issues affecting absorption.
  • Have any other significant uncontrolled health condition.

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