Trial Title:
177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry
NCT ID:
NCT06395402
Condition:
Neuroendocrine Tumors
Neuroendocrine Tumor Grade 1
Neuroendocrine Tumor Grade 2
Conditions: Official terms:
Neuroendocrine Tumors
Lutetium Lu 177 dotatate
Conditions: Keywords:
lutetium Lu 177 dotatate
Radiotherapy Planning, Computer-Assisted
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized controlled trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lutetium Lu 177 dotatate therapy
Description:
LUTATHERA is an FDA approved radiopharmaceutical therapy for gastroenteropancreatic
neuroendocrine tumor (GEP-NET). This radiopharmaceutical binds to somatostatin receptors,
which are overexpressed on GEP-NET cells, and subsequently delivers beta particle
radiation to the tumor cells.
Arm group label:
Dosimetry-based lutetium Lu 177 dotatate therapy
Arm group label:
Standard lutetium Lu 177 dotatate
Other name:
Lutathera
Summary:
The goal of this study is to learn if individualized dosimetry-based prescribing of
Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals) improves treatment outcomes
for adults with unresectable neuroendocrine tumors. To investigate this, study
participants will:
- Undergo Somatostatin Receptor (SSTR) positron emission tomography (PET) imaging,
such as a DOTATOC PET/CT scan
- Be randomized to receive standard treatment (as per FDA guidelines) or
investigational treatment (customized dosing of Lutathera based upon dosimetry)
- Undergo blood tests for 4 to 8 weeks after each Lutathera treatment
- Complete patient reported outcome questionnaires
- Visit the clinic for follow-up about every 8 weeks.
Detailed description:
This is a randomized controlled clinical trial evaluating the impact of forward planning
dosimetry for Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals), a
radiopharmaceutical approved to treat neuroendocrine tumors by the U.S. FDA.
If a patient consents to participate, and is deemed eligible to move forward, there is a
2 out of 3 chance to receive the investigational treatment (the Lutathera treatment
customized to tumor uptake and kidney uptake). The standard treatment is 200 millicuries
(mCi) of Lutathera per cycle, with potential adjustments for safety per the FDA-approved
package insert.
Regardless of the assigned group (investigational treatment or standard treatment), the
first treatment is 200 mCi. This is given with amino acids, which is required for this
treatment.
Participants in the standard treatment continue to receive 200 mCi per treatment, with or
without adjustment based on package insert instructions, for up to 4 treatments total.
Participants in the investigational treatment will receive a customized dose of
Lutathera, up to 400 mCi per treatment for treatments 2 - 4, in the hopes that escalation
will be safe and effective in many patients based on individualized dosimetry.
Participants randomized to the investigational treatment will receive specialized imaging
(SPECT/CT) following administration of Lutathera. This will identify where the Lutathera
went and how long it remains there (in the tumors, kidneys, or bone marrow). After the
first dose of Lutathera, this imaging is done on the first day of treatment and then once
a day for the next 3 to 4 days. Each scan lasts about an hour. Following treatments 2 and
3, this imaging is only done on the first day and then once at about 3 to 4 days after
the treatment. There are also blood samples collected to measure the radioactivity in the
blood.
All participants must be actively followed to assess for side effects of therapy as well
as treatment outcomes. This means participants must return to the treatment site at 2, 3,
6, and 12 months after the last cycle of therapy. All participants must have a CT scan
completed at 6 months after treatment as well.
Radiation side effects can take years to develop. For this reason, it is very important
that participants remain in touch with the study investigator and team. Participants have
life-long follow-up for this study.
Criteria for eligibility:
Criteria:
In order to be eligible to participate in this study, an individual must meet all of the
following criteria. A physical, with vital signs, concomitant medication review, and
medical history must be completed within 60 calendar days to confirm appropriateness of
Lutathera treatment as well as to foundation for listed criteria.
Inclusion Criteria:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the
duration of the study.
- Aged ≥ 18 years at time of consent.
- Pathologically confirmed (histology or cytology) malignant neoplasm that is
determined to be a well-differentiated neuroendocrine tumor (Ki-67 ≤ 20%) with the
primary tumor location known or believed to be gastroenteropancreatic origin
(GEP-NET)
- Disease measuring ≥ 1.5 cm in diameter on CT or MRI as measured per RECIST that
shows uptake > liver background on sstr2 PET/CT with any FDA approved sstr2 imaging
agent. SSTR2 PET/CT must have been obtained within 90 days prior to scheduled C1D1
of Lutathera.
- Recommended to receive LUTATHERA® therapy for unresectable and/or metastatic
neuroendocrine disease.
- Adequate performance status (ECOG of 0 or 1; or Karnofsky performance status of
≥70).
- Agrees to contraception during therapy.
- Neutrophil count within normal limits within 28 days of treatment day 1.
- Platelet count within normal limits within 28 days of treatment day 1.
- Ability to take oral medication and be willing to adhere to the treatment regimen
- For individuals of reproductive potential: agreement to use effective birth control
- Agreement to adhere to Lifestyle Considerations throughout study duration: abstain
from caffeine or xanthine-containing products as well as alcohol before the start of
cycle dosing and through the cycle's final blood sample; minimize social
interactions during low blood counts.
Exclusion Criteria:
- Individuals who are pregnant or lactating (note: potential participants should not
engage in 'pump & dump' strategy; lactation must be discontinued).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection (requiring inpatient admission or a delay to start of therapy), fever,
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,
or psychiatric illness/social situations that would limit compliance with study
requirements.
- Surgery, radiation therapy, or chemotherapy ≤ 4 weeks of C1D1 (Toxicities from prior
therapies should have resolved to ≤ CTCAE grade 1 or a new baseline established).
- Prior peptide-receptor radiotherapy (PRRT).
- Therapeutic investigational drug within 4 weeks of C1D1 (imaging agents are
acceptable).
- A concurrent malignancy that, in the opinion of the investigator, would cause a
safety risk by delaying therapy or confound/negatively impact study objectives
(documentation of the rationale must be provided)
- Prior external beam radiation dose to the kidneys of >10 Gy (mean dose to functional
renal volume).
- Prior external beam radiation (including brachytherapy) involving 25% of the bone
marrow (excluding scatter doses of ≤ 5 Gy) as estimated by a radiation oncologist.
- History of allergic reactions attributed to compounds of similar chemical or
biologic composition to Octreoscan® or Netspot™.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Holden Comprehensive Cancer Center at the University of Iowa
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristin Gaimari-Varner, RN, BSN
Phone:
319-384-9495
Email:
kristin-gaimari-varner@uiowa.edu
Contact backup:
Last name:
Kellie Bodeker, Ph.D.
Phone:
319-384-9425
Email:
kellie-bodeker@uiowa.edu
Investigator:
Last name:
David Bushnell, MD
Email:
Sub-Investigator
Investigator:
Last name:
Yusuf Menda, MD
Email:
Sub-Investigator
Investigator:
Last name:
Janet Pollard, MD
Email:
Sub-Investigator
Investigator:
Last name:
Parren McNeely, MD
Email:
Sub-Investigator
Investigator:
Last name:
Michael Graham, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Kristin Plichta, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Stephen Graves, PhD
Email:
Principal Investigator
Start date:
May 3, 2024
Completion date:
December 31, 2029
Lead sponsor:
Agency:
University of Iowa
Agency class:
Other
Collaborator:
Agency:
Novartis
Agency class:
Industry
Source:
University of Iowa
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06395402
