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Clinical Trial · NCT01099228
Combination Targeted Radiotherapy in Neuroendocrine Tumors
Overview
The primary aim of this project is to determine, what fraction of individuals with neuroendocrine tumors would show substantially improved tumor dosimetry with combined agent therapy compared to "best" single agent therapy and determine the magnitude of the potential tumor radiation dose increase.
Sponsor
University of Iowa
Phase
N/A
Contacts
David Bushnell, M.D. (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT01099228Drug / Compound
DOTATOC
Isotope(s):
IODINE-131
Radioisotope: I-131
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 8 Days
Decay Mode: BETA, GAMMA
Energy: βeta max 0.6 MeV Gamma 364 keV
Range: In Tissue: 0.8 -2.1 mm
Decay Daughters: Xe131
Status: FDA Approval: 1951-First FDA Approved Radiopharmaceutical), AZEDRA® (2018)
Target(s):
- SSTR2
Ligand Class: Peptides
Chelator: DOTA
MIBG
Isotope(s):
IODINE-131
Radioisotope: I-131
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 8 Days
Decay Mode: BETA, GAMMA
Energy: βeta max 0.6 MeV Gamma 364 keV
Range: In Tissue: 0.8 -2.1 mm
Decay Daughters: Xe131
Status: FDA Approval: 1951-First FDA Approved Radiopharmaceutical), AZEDRA® (2018)
Target(s):
- NET
Ligand Class: Small Molecules
Eligibility
Inclusion
- Subjects with biopsy-proven metastatic (soft tissue) neuroendocrine tumors.
- Subjects with a Southwest Oncology Group (SWOG) performance score of 0-2 and an expected median survival of at least 6 months.
Exclusion
- Renal insufficiency with a serum creatinine 2 X ULN
- Subjects receiving Sandostatin LAR \< 21 days prior to dosing or Sandostatin Immediate Release (IR) \< 24 hours prior to dosing.
- Subjects who because of their weight and body distribution do not fit into the imaging machine.
- Prior chemotherapy, radiotherapy or any investigational drugs within 60 days prior admission into this study. Patients must have recovered from all therapy-related toxicities
- Subjects who use medications that are known to interfere with MIBG uptake and is unable to discontinue for medical reasons.
- Female patients who are pregnant or breast feeding. Women of childbearing potential must have a negative serum/urine pregnancy test within 48 hours prior to administration of study treatment.
- Subjects unable to lie still for the imaging studies.
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