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A Phase II Randomized Control Trial of Triapine Plus Lutetium Lu 177 Dotatate Versus Lutetium Lu 177 Dotatate Alone for Well-Differentiated Somatostatin Receptor-Positive Neuroendocrine Tumors

Clinical Trial Details

This study proposes to test if the study drug triapine is an effective radiation sensitizer that can be safely combined with peptide receptor radionuclide therapy (PRRT) and can improve antitumor activity of the PRRT Lutetium Lu 177 Dotatate for well-differentiated somatostatin receptor-positive neuroendocrine tumors.

Triapine is a type of drug called a ribonucleotide reductase (RNR) inhibitor. RNR is a key enzyme involved in DNA synthesis, is directly involved in the cellular response to radiation. RNR is the only enzyme responsible for the formation of deoxyribonucleotide diphosphate (dNDP), the key building blocks for DNA synthesis.

The purpose of this study is to compare the usual treatment of PRRT alone to using triapine plus PRRT. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach.

This targeted radiation-based treatment, Lutetium Lu 177 Dotatate, is already approved by the U.S. Food and Drug Administration (FDA) to treat neuroendocrine cancer, but it is considered investigational in this study because it is not yet approved by the FDA in combination with triapine. 

Participants will be randomly assigned to one of two study groups. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Group 1 will receive Lutetium Lu 177 Dotatate through a vein in the arm once each cycle on Day 1, for a total of 4 cycles. Each cycle lasts 8 weeks (56 days). Lutetium Lu 177 Dotatate will be administered by slow intravenous infusion (IV) over a 30-minute time span.

Group 2 will receive triapine plus Lutetium Lu 177 Dotatate. Lutetium Lu 177 Dotatate will be administered through a vein in the arm once each cycle on Day 1, for a total of 4 cycles. Lutetium Lu 177 Dotatate will be administered by slow intravenous infusion (IV) over a 30-minute time span. Triapine will be taken by mouth once a day on Days 1-14 of each cycle, for a total of 4 cycles. Each cycle lasts 8 weeks (56 days).

Key Eligibility: 
  1. 18 years or older
  2. A diagnosis of metastatic, neuroendocrine tumor with positive gallium 68 DOTATATE or copper 64 DOTATATE scan (patients with lung neuroendocrine tumors are excluded). 

Detailed eligibility will be discussed when reaching out to the study team.    

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2306026195

ClinicalTrials.gov:

NCT05724108

Sponsor:

NCI

Status

Open to Enrollment

Age Group

Adult

Sponsor