Meningioma, Glioblastoma, Acoustic Neuroma, Brain Cancer, Pituitary Adenoma
Conditions
Keywords
Cancer, Malignant, Benign, Glioblastoma, Meningioma, Pituitary Adenoma, Acoustic Neuroma, Brain Masses, Intracranial Lesion
Brief summary
This pilot clinical study evaluates the safety and imaging performance of panitumumab-IRDye800 (pan800), a fluorescent, EGFR-targeted imaging agent - in patients undergoing neurosurgical resection of intracranial lesions.
Detailed description
This study will evaluate a single intravenous dose of panitumumab-IRDye800 (pan800) in subjects with intracranial lesions who are scheduled to undergo standard-of-care neurosurgical resection. The study drug will be administered 1-5 days prior to surgery, after which participants will undergo their planned procedure with intraoperative near-infrared fluorescence imaging to assess tumor visualization. Following the infusion, subjects will be monitored for immediate adverse events, and a member of the study team will continue safety follow-up through postoperative assessments and a Day 15 follow-up contact. Participants will otherwise continue to receive standard-of-care evaluation and treatment for their intracranial disease at the discretion of their treating physicians.
Interventions
Subjects receive a single infusion of panitumumab-IRDye800 (pan800) and will undergo near-infrared fluorescence imaging during their neurosurgical procedure 1-5 days after the infusion.
Sponsors
Eben Rosenthal
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with intracranial lesions undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are deemed to be candidates for resection. * Subject age ≥ 18 years. * Adequate hematologic and end-organ function appropriate for surgery and panitumumab infusion as determined by routine preoperative evaluation or designee prior to infusion. If liver function, renal function, and hematologic laboratory test results are acceptable for elective surgery and panitumumab infusion, the patient is considered eligible for the study. Laboratory results will need to be obtained within 30 days prior to initiation of study treatment include: 1. Chemistry Panel - Potassium, BUN (or urea), and Creatinine 2. CBC with differential - WBC, including ANC, hemoglobin, hematocrit, and platelet count 3. Magnesium and Phosphorus * Women of childbearing potential must have a negative pregnancy test within 7 days of study drug administration. * Ability to understand and willingness to sign a written informed document or written informed consent via a surrogate consent rider from the patients' healthcare decision maker.
Exclusion criteria
* Had a myocardial infarction, cerebrovascular accident, or uncontrolled chronic heart failure within 6 months prior to enrollment. * History of infusion reactions to any monoclonal antibody therapies. * Women who are currently pregnant or breastfeeding. * Participants presenting with a baseline QTcF interval \> than 480 milliseconds. * Magnesium or phosphorus lower than normal institutional values, and subject is symptomatic. * Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. * Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis. * Patients with severe renal disease or anuria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the safety of panitumumab-IRDye800 as an imaging agent in patients undergoing surgery for intracranial lesions. | From infusion to 15 days post-infusion. | Safety will be defined by the number of Grade ≥ 2 AEs determined that are clinically significant and considered definitely or probably related to pan800. Safety data will be summarized by grade, severity, and type. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the efficacy of panitumumab-IRDye800 in identifying intracranial lesions compared to surrounding normal central nervous system tissue. | Within 14 days post-surgery | Efficacy will be measured by tumor-to-background ratio (TBR) using fluorescence intensity measurements. |
| Determine the dosage of the study drug infusion to maximize the tumor-to- background ratio. | Within 14 days post-surgery | There will be an assessment of tumor-to-background ratio (TBR) comparing cohort 1 \& 2. |
| Determine the optimal timing of the study drug infusion to maximize the tumor-to- background ratio. | Within 14 days post-surgery | There will be an assessment of tumor-to-background ratio (TBR). Some patients may receive the study drug on varying pre-surgery days rather than infusions on the same day for every patient. The TBR will be assessed for every patient regardless of pre-surgery infusion day. The optimal timing of administration of the study drug will be determined by the highest average TBR from a particular pre-surgery infusion day. TBR will still be assessed using the intraoperative fluorescence imaging taken on the standard of care surgery. |
Contacts
CONTACTMakenna Brown
CONTACTNicole Jones
PRINCIPAL_INVESTIGATORPeter Morone, MD
Vanderbilt University Medical Center
Outcome results
None listed