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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 : Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE November 18, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date April 26, 2019
Study Start Date  ICMJE November 13, 2015
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02609737 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Theranostics of Radiolabeled Somatostatin Antagonists 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in Patients With Neuroendocrine Tumors
Official Title  ICMJE Theranostics of Radiolabeled Somatostatin Antagonists 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in Patients With Neuroendocrine Tumors
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE
  • Device: PET/CT Imaging
  • Radiation: 68Ga-DOTA-JR11
  • Radiation: 177Lu-DOTA-JR11
Study Arms  ICMJE 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.
Interventions:
  • Device: PET/CT Imaging
  • Radiation: 68Ga-DOTA-JR11
  • Radiation: 177Lu-DOTA-JR11
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 18, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02609737
Other Study ID Numbers  ICMJE 15-161
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lisa Bodei, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP