Testing the Addition of an Anti-cancer Drug, Triapine, to the Usual Radiation-Based Treatment (Lu… (NCT04234568) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Testing the Addition of an Anti-cancer Drug, Triapine, to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Neuroendocrine Tumors
United States31 participantsStarted 2020-07-20
Plain-language summary
This phase I trial studies the side effects and best dose of triapine when given together with lutetium Lu 177 dotatate in treating patients with neuroendocrine tumors. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. Giving triapine and lutetium Lu 177 dotatate together may work better to treat patients with neuroendocrine tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Metastatic, histologically confirmed well-differentiated neuroendocrine tumor with positive dotatate scan (gallium-68 or copper-64) within 6 months. Lesions on dotatate scan (gallium-68 or copper-64 dotatate scan) will be considered positive if the maximum standard uptake value (SUVmax) is \> 2 times SUV mean of normal liver parenchyma
* Failure of at least one prior systemic cancer treatment, including somatostatin analogs
* Patients must have progressive disease based on RECIST criteria, version 1.1 evidenced with CT scans/MRI obtained within 24 months from enrollment
* Patients must have measurable disease per RECIST 1.1
* No prior exposure to peptide receptor radionuclide therapy
* Recovered from adverse events of previously administered therapeutic agents to grade 1 or less toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
* Archival tissue no longer than 6 months old should be present, otherwise baseline research biopsy is needed for WES
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of triapine in combination with lutetium Lu 177 dotatate in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
* Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2 (Karnofsky \>= 60%)
* Leukocytes \>= 2,000/mcL
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 75,000/mcL
* Total bilirubin =…
What they're measuring
1
Maximum Tolerated Dose (MTD) of Triapine and Recommended Phase 2 Dose (RP2D)