TheranosticTrials.org

Clinical Trial · NCT02609737

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

Overview

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).

Sponsor

Memorial Sloan Kettering Cancer Center

Phase

N/A

Contacts

Lisa Bodei, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02609737

Drug / Compound

DOTA-JR11

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

DOTA-JR11

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Hemoglobin ≥ 9.0 g/dL
  • 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.
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
  • Total bilirubin ≤ 1.25 x Upper Limit Normal (ULN)
  • Patients must not have disease that is currently amenable to surgery. Prior surgery is allowed no less than 6 weeks prior to study entry.
  • Progressive metastatic disease defined by one of the following, occurring within 6 months of study entry:
  • At least one metastasis must show uptake of 111In-DTPA-octreotide on SPECT that is higher than the physiologic radiotracer uptake by the liver
  • Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) calculated CrCl ≥ 60 mL/min/1.73m\^2
  • ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
  • AST (SGOT)/ ALT(SGPT) ≤ 2.5 x ULN with liver metastases
  • Symptomatic disease (including worsening hormonal symptoms or symptoms related to tumor burden)
  • Patients must have normal organ and marrow function as defined below:
  • Measurable disease as defined by RECIST 1.1.
  • Appearance of any new lesion
  • At least a 20% increase in radiologically or clinically measurable disease
  • Leukocytes ≥ 3.0 x 109/L
  • 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.
  • Alkaline phosphatase \< 2 x ULN (if known liver or bone disease)
  • Histologically or cytologically confirmed metastatic and/or unresectable progressive, well differentiated carcinoid or pancreatic NET carcinoids
  • Serum albumin \> 30 g/L, or serum albumin = 30 g/L but normal prothrombin time
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
  • Platelets ≥ 200 x 10\^9/L

Exclusion

  • Known CNS metastases and/or carcinomatous meningitis
  • Toxicities from prior therapies that have not resolved to grade 1 or grade 0
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTA-JR11 as assessed from medical records
  • Active malignancy of metastatic potential other than the known carcinoid or pancreatic NET within the past three years
  • Treatment with short-acting somatostatin analogs less than 3 days and Sandostatin® depot injection less than 5 weeks before scanning and treatment
  • Life expectancy \< 6 months as assessed by the treating physician.
  • 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
  • \>20% bone marrow external beam radiotherapy and/or previous radioisotope therapy
  • Women who are pregnant or breastfeeding