Theranostics of Radiolabeled Somatostatin Antagonists 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in Patients With Neuroendocrine Tumors
1 other identifier
interventional
20
1 country
1
Brief Summary
This study has 3 steps and not everyone will have all 3 steps done. The overall goals are to see if a new experimental drug is safe to image (step 1) and treat neuroendocrine tumors (step 2 and 3).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 13, 2015
CompletedFirst Submitted
Initial submission to the registry
November 18, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2020
CompletedResults Posted
Study results publicly available
February 1, 2022
CompletedFebruary 1, 2022
December 1, 2020
5.1 years
November 18, 2015
January 3, 2022
January 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
according to RECIST 1.1 and median progression-free and overall survival will be estimated and reported with 95% confidence intervals
2 years
Study Arms (1)
68Ga-DOTA-JR11 and 177Lu-DOTA-JR11
EXPERIMENTALPts get a PET/CT study with approx.150-200 MBq of 68Ga-DOTA-JR11. Lesions with focal radiotracer uptake not explained by physiologic sstr2 expression will be interpreted as metastatic disease. If 68Ga-DOTA-JR11 uptake by metastases with a diameter of more than 2 cm is less than the physiologic radiotracer uptake by the liver, no further imaging \& therapy will be performed as part of the study, as it is unlikely that pts with this low radiotracer uptake will benefit from PRRT (2). All other pts will undergo a dosimetric study with 1850 MBq (less than 100 μg peptide) of 177Lu-DOTA-JR11. Results of the dosimetry study, will determine the balance of activity of 177Lu-DOTA-JR11 that can be administered without exceeding the radiation dose limits. This activity will be split into 2 equal amounts to be delivered in 2 cycles, approximately 3 months apart. After each therapy cycle, pts will be followed clinically for 3 months.
Interventions
Eligibility Criteria
You may qualify if:
- Ability to understand and the willingness to sign a written informed consent document
- Adults ≥ 18 years old
- Histologically or cytologically confirmed metastatic and/or unresectable progressive, well differentiated carcinoid or pancreatic NET carcinoids
- Progressive metastatic disease defined by one of the following, occurring within 6 months of study entry:
- At least a 20% increase in radiologically or clinically measurable disease
- Appearance of any new lesion
- Symptomatic disease (including worsening hormonal symptoms or symptoms related to tumor burden)
- Measurable disease as defined by RECIST 1.1.
- At least one metastasis must show uptake of 111In-DTPA-octreotide on SPECT that is higher than the physiologic radiotracer uptake by the liver
- ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
- Patients must have normal organ and marrow function as defined below:
- Leukocytes ≥ 3.0 x 109/L
- Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
- Hemoglobin ≥ 9.0 g/dL
- Platelets ≥ 200 x 10\^9/L
- +9 more criteria
You may not qualify if:
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTA-JR11 as assessed from medical records
- Life expectancy \< 6 months as assessed by the treating physician.
- Treatment with short-acting somatostatin analogs less than 3 days and Sandostatin® depot injection less than 5 weeks before scanning and treatment
- 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
- Women who are pregnant or breastfeeding
- Toxicities from prior therapies that have not resolved to grade 1 or grade 0
- Known CNS metastases and/or carcinomatous meningitis
- Active malignancy of metastatic potential other than the known carcinoid or pancreatic NET within the past three years
- \>20% bone marrow external beam radiotherapy and/or previous radioisotope therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Lisa Bodie, MD, PhD
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Bodei, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2015
First Posted
November 20, 2015
Study Start
November 13, 2015
Primary Completion
December 10, 2020
Study Completion
December 10, 2020
Last Updated
February 1, 2022
Results First Posted
February 1, 2022
Record last verified: 2020-12