Theranostics of Radiolabeled Somatostatin Antagonists 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in Patients With Neuroendocrine Tumors

January 3, 2022 updated by: Memorial Sloan Kettering Cancer Center
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
    • Total bilirubin ≤ 1.25 x Upper Limit Normal (ULN)
    • AST (SGOT)/ ALT(SGPT) ≤ 2.5 x ULN with liver metastases
    • Alkaline phosphatase < 2 x ULN (if known liver or bone disease)
    • Serum albumin > 30 g/L, or serum albumin = 30 g/L but normal prothrombin time
    • Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) calculated CrCl ≥ 60 mL/min/1.73m^2
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
  • Previous local therapy (e.g., chemoembolization or bland embolization) is allowed if completed > 6 weeks prior to study entry. For such patients, there must be either progression of measurable disease documented within the treatment field, or measurable progressive disease outside the treatment field prior to study entry.
  • Previous chemotherapy and/or investigational agents are allowed if completed > 4 weeks prior to study entry (> 6 weeks if last regimen contained bis-chloroethyl nitrosourea (BCNU) or mitomycin C). For patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease since receiving systemic therapy prior to study entry.
  • Patients must not have disease that is currently amenable to surgery. Prior surgery is allowed no less than 6 weeks prior to study entry.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11
Pts 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.
Device: PET/CT Imaging
Radiation: 68Ga-DOTA-JR11
Radiation: 177Lu-DOTA-JR11

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: 2 years
according to RECIST 1.1 and median progression-free and overall survival will be estimated and reported with 95% confidence intervals
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa Bodei, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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