Study to Evaluate the Safety of Combining Two Radionuclide Therapies to Treat Mid-gut Neuroendocrine Tumors

What Was Tested

In this early phase 1 trial, researchers set out to test Octreotide.

These drugs (131I-MIBG, 90Y-DOTATOC) are radioactive drugs, known as radionuclide therapy.

It had eight arms (groups): Cohort 1 (experimental), Cohort 2 (experimental), Cohort 3 (experimental), Cohort -1 (alternative cohort) (experimental) and Cohort 2.1 (renal alternative) (experimental).

This is the initial treatment arm. 131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart. Radiation exposure to the bone marrow is limited to 150 centiGray (cGy) Radiation exposure to the kidneys is limited to 1900 centiGray (cGy).

This treatment arm is opened if Cohort 1 is successful. 131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart. Radiation exposure to the bone marrow is limited to 200 centiGray (cGy) Radiation exposure to the kidneys is limited to 2300 centiGray (cGy).

This treatment arm is opened if Cohort 2 is successful. 131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart. Radiation exposure to the bone marrow is limited to 250 centiGray (cGy) Radiation exposure to the kidneys is limited to 2300 centiGray (cGy).

The registry classes the interventions as drug.

More on the Plan

\[131\]Iodine-MIBG and \[90\]Yttrium-DOTATOC are radioactive drugs designed to treat specific tumor cells.

These drugs are a combination of the radiation (131-Iodine, 90-Yttrium) and a protein that targets the tumor cell (MIBG or DOTATOC).

Two organs still absorb some of the radiation, though: bone marrow and the kidney.

These organs limit how much radiation can be given to tumors, but the researchers don't know how much radiation is too much.

Who Took Part

Enrollment: 20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ability to understand and the willingness to provide informed consent. ≥1 evaluable site of disease measuring ≥ 1.5 cm in diameter on CT or MRI as measured per RECIST. ≥ 18 to 70 years at the time of study drug administration. Agrees to contraception.

The full record lists 9 inclusion and 25 exclusion criteria; among the exclusions: patients who are considered a fall risk; women who are pregnant or breast feeding; surgery, radiation or chemotherapy within 4 weeks of proposed step 1 start date.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-05-07 with completion listed for 2025-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: glomular filtration rate (eGFR) (time frame: 4 and 8 weeks after each treatment, then at 3, 6, & 9 months after the last treatment). urine protein (time frame: Monthly beginning 4 weeks after the first treatment through 6 months after the last treatment).

It also tracked 2 secondary outcomes, for example Progression free survival (PFS) and Overall survival (OS).

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Octreotide in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.