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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609737
Recruitment Status : Completed
First Posted : November 20, 2015
Results First Posted : February 1, 2022
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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).

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Device: PET/CT Imaging Radiation: 68Ga-DOTA-JR11 Radiation: 177Lu-DOTA-JR11 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Theranostics of Radiolabeled Somatostatin Antagonists 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in Patients With Neuroendocrine Tumors
Actual Study Start Date : November 13, 2015
Actual Primary Completion Date : December 10, 2020
Actual Study Completion Date : December 10, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609737


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Lisa Bodei, MD Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] September 9, 2020

More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02609737    
Other Study ID Numbers: 15-161
First Posted: November 20, 2015    Key Record Dates
Results First Posted: February 1, 2022
Last Update Posted: February 1, 2022
Last Verified: December 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Radiolabeled Somatostatin Antagonists
68Ga-DOTA-JR11
177Lu-DOTA-JR11
 Pet scan
CT scan
15-161
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Nerve Tissue
1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action