This is a safety study to determine the recommended dose to test in clinical trials. The study involves two treatments with 212Pb (212-lead) VMT-α-NET. This is a safety study only; it will most likely not provide therapeutic benefit.
This research study is designed to explore if a new radiotherapeutic (radioactive) drug, named 212Pb (212-lead) VMT-α-NET, works against neuroendocrine tumor cells. To begin researching this drug, we need to determine if \[212Pb\] VMT-α-NET is safe and tolerable when used as a cancer treatment. As a safety study, it is unknown if the treatment is safe or effective. The study will also estimate the radiation dose to the kidneys for this treatment. To calculate this radiation dose, imaging is also performed with the sister drug, \[203Pb\] VMT-α-NET using SPECT/CT imaging. Each participant is assigned a radiation dose to the kidneys that cannot be exceeded. The study is testing the safety of the specific radiation dose to the kidneys when using \[212Pb\] VMT-α-NET. Participants are assigned a radiation dose based on how other participants have tolerated the \[212Pb\] VMT-α-NET. The amount of \[212Pb\] VMT-α-NET administered varies person-to-person because of each person's unique tumor uptake of \[203Pb\] VMT-α-NET and how long it lasts in the body. The study involves 2 treatments, about 8 to 10 weeks apart. The drug is given by infusion once per treatment. The participants also receive an infusion of amino acids to help protect the kidneys as well as medications to help protect against nausea (feeling sick to the stomach). Once a participant is administered the \[212Pb\] VMT-α-NET, they must be followed (i.e. come back to the clinic) for at least 6 months for safety assessments. Safety assessments include blood tests to check bone marrow, kidney, and liver function as well as urinary tests to check kidney function. Participants will also have imaging at 6 months post-treatment to measure how their tumors responded to therapy. Participants will have lifelong follow-up for this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Up to 2 infusions with \[212Pb\] VMT-α-NET, each infusion separated by at least 8 weeks. During each infusion, the participants also receive an infusion with lysine and arginine (amino acids) to help reduce kidney damage.
The \[203Pb\] VMT-α-NET SPECT/CT is performed for all participants to determine trial eligibility as well as for the calculations to determine the estimated radiation dose to kidneys. This involves three imaging sessions of about 2 hours each over 2 days. The participants also receive an infusion with lysine and arginine (amino acids) to help reduce kidney damage at the time they receive the injection of . \[203Pb\] VMT-α-NET, a radioactive tracer drug.
Holden Comprehensive Cancer Center at the University of Iowa
Iowa City, Iowa, United States
Determine recommended therapeutic dose of [212Pb] VMT-α-NET
Determine the recommended phase 2 dose for therapy with \[212Pb\]VMT-Α-NET administered intravenously to patients with neuroendocrine tumors that have progressed despite therapy.
Time frame: From study day 1 through 6 months post-treatment
Objective Response Rate (ORR)
Determine objective response rate using the standardized technique (RECISTv1.1) in patients with treatment refractory neuroendocrine tumors (NETs) when treated with \[212Pb\] VMT-α-NET. Objective response rate is the incidence of complete response and partial response added together.
Time frame: At 6 months post-treatment
Maximum tolerated radiation dose for kidneys
Determine the maximum tolerated critical organ dose limit for kidneys for therapy with \[212Pb\]VMT-α-NET administered intravenously to patients with neuroendocrine tumors that have progressed despite therapy. Maximum tolerated radiation dose is indicated by the number and severity of renal (i.e. kidney) toxicities observed through 12 months post-treatment.
Time frame: From study day 1 through 12 months post treatment
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