Clinical trial NCT02901925: A Microdose Evaluation Study of ABY-029 in Recurrent Glioma
Official title: A Phase 0 Open Label, Single-center Clinical Trial of ABY-029, an Anti-EGFR Fluorescence Imaging Agent Via Single Intravenous Injection to Subjects With Recurrent Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Glioma
Keywords: ABY-029
Affibody
Molecular Fluorescence-Guided Surgery
Epidermal Growth Factor Receptor (EGFR)
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
name: National Cancer Institute (NCI)
First posted: 2016-09-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Pilot feasibility study
Primary purpose: BASIC_SCIENCE

Brief summary: The primary study objective is to determine if microdoses of ABY-029 lead to detectable signals in sampled tissues with an EGFR pathology score ≥ 1 based on histological staining.

The secondary study objective is to assess diagnostic accuracy of ABY-029 detection by iFI and intraoperative probe relative to histopathology diagnosis, and other indicators (e.g. proliferation, infiltration, etc.) as the gold standard, and to measure the molecular uptake and concentration of ABY-029 in resected specimens.

Detailed description: The investigators plan a sample size of 6-12 patients in this open label, single center, clinical trial of ABY-029. Administration will occur as a single intravenous injection to subjects with recurrent glioma, approximately 1-3 hours prior to surgery.

The protocol is not a safety study since no physiological effects are expected at microdose levels of ABY-029. Rather, doses have been selected to determine if a fluorescence signal can be detected by wide-field imaging technology with a signal-to-noise ratio of 10, which is considered necessary for subsequent assessment of diagnostic performance of ABY-029 as a tumor biomarker sufficient to guide surgical resection in the future. No diagnostic or therapeutic intent is proposed, and administration of the study drug is not intended to alter the extent of planned brain tumor resection during the surgical procedure.

Eligibility criteria: Inclusion Criteria:

1. Preoperative diagnosis of recurrent high-grade glioma having EGFR positive tissue from prior surgery.
2. Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
3. Valid informed consent by subject.
4. Age ≥ 18 years old.

Exclusion Criteria:

1. Pregnant women or women who are breast feeding.
2. Patients on any experimental anti-EGFR targeted therapies

Primary outcomes:
measure: Fluorescence Signal Detection
timeFrame: during procedure
Secondary outcomes:
measure: Mean Tumor-to-background Ratio
timeFrame: during procedure
measure: Ex Vivo Fluorescence Intensity
timeFrame: post surgical
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: David W Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References: