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

Running, not enrolling · Early Phase 1

Conditions studied: Neuroendocrine Tumor, Malignant, Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting

In brief

This study is designed to identify the best tolerated doses of \[131\]Iodine-MIBG and \[90\]Yttrium-DOTATOC when co-administered to treat midgut neuroendocrine tumors. These drugs (131I-MIBG, 90Y-DOTATOC) are radioactive drugs, known as radionuclide therapy. Currently, the safest and best tolerated doses of these drugs (when combined together) is unknown.

Key facts

Study ID

NCT03044977

Run by

David Bushnell

People needed

20

Starts

2017-05-07

Expected to finish

2027-12-01

Last updated by the study team

2023-08-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to understand and the willingness to provide informed consent.
• A pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be well-differentiated neuroendocrine tumor (i.e. grade 1 or grade 2). The primary tumor location should be known or believed to be midgut, or pheochromocytoma, or paraganglioma.
• Disease not amenable to curative intent treatment (primarily surgery) and in addition has shown either clinical or radiographic progression on all available (non-radionuclidic) therapies known to confer clinical benefit.
• SSTR positive sites as demonstrated by either SSTR2 positivity (2+ or 3+ intensity and greater than 10% tumor cell occupying the receptors) or a nuclear medicine scan utilizing 111In-DTPA-Phe3-Octreotide (Octreoscan™) or 68Ga-DOTA-tyr3-Octreotide within 12 months prior to anticipated C1D1 demonstrating SSTR positive tumor sites
• ≥1 tumor site must have demonstrated uptake equal to or greater than normal liver as documented by nuclear scan imaging
• ≥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.
• Karnofsky Performance Status at least 70%
• Agrees to contraception.

You may not qualify if…

• 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.
• Prior peptide-receptor radiotherapy (PRRT).
• Investigational drug within 4 weeks of proposed step 1 start date.
• More than one concurrent, malignant disease.
• History of congestive heart failure and cardiac ejection fraction ≤ 40%.
• Patients for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk.
• Patients who are unable to discontinue medications known to affect MIBG uptake
• Proteinuria, grade 2 (i.e., ≥ 2+proteinuria).
• Long-acting somatostatin analogue treatment within 14 days of proposed step 1 start date.
• Prior external beam radiation involving kidneys (scatter doses of < 500 cGy to a single kidney or radiation to < 50% of a single kidney is acceptable).
• Prior external beam radiation (including brachytherapy) involving 25% of bone marrow (excluding scatter doses of ≤ 5 Gy).
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 90Y-DOTA-tyr3-Octreotide, Octreoscan®, 68Ga-Octreotide, or 131I-MIBG.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• If a subject meets STEP 1 criteria, a serial SPECT scan is performed for dosimetry. Step 2 criteria must be met and verified prior to therapy initiation.
• STEP 2:
• Inclusion Criteria:
• Subjects must demonstrate at least one of the following:
• One or more MIBG+ and DOTATOC- tumors in addition to one or more DOTATOC+ tumors, and/or,
• One or more tumor sites where the calculated "safe" radiation tumor dose is higher by at least 25% with a combination of 131I-MIBG and 90Y-DOTATOC than it is with 90Y DOTATOC alone, or,
• Within 2 weeks of study drug administration for therapeutic intent, patients must have normal organ and marrow function as defined below:
• absolute neutrophil count ≥ 2000 cells/mm3
• platelets ≥100,000 cells/mm3
• total bilirubin <1.5 x institutional ULN for age and weight

Where it is running

• Holden Comprehensive Cancer Center — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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