Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Phase 2RecruitingNCT03510208

Stanford University46 enrolled

Overview

The phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who undergo surgery. Panitumumab-IRDye800 can attach to tumor cells and make them more visible using a special camera during surgery, which may help surgeons better distinguish tumor cells from normal brain tissue and identify small tumors that cannot be seen using current imaging methods.

PRIMARY OBJECTIVES: I. Determine/verify the safety and pharmacokinetic profile of panitumumab conjugated to the optical dye IRDye800CW (panitumumab-IRDye800), as an imaging agent in patients undergoing surgery for malignant glioma. SECONDARY OBJECTIVES: I. Determine the efficacy of panitumumab IRDye800 in identifying malignant glioma compared to surrounding normal central nervous system tissue. II. Determine whether a loading dose of panitumumab is necessary to achieve an effective tumor-to-background ratio. III. Determine the optimal timing of the surgical procedure to maximize the tumor-to-background ratio. OUTLINE: This is a phase I, dose escalation study of panitumumab-IRDye800 followed by a phase II study.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Malignant Brain Neoplasm Malignant Glioma

Interventions

Near-Infrared Fluorescence ImagingPROCEDURE

Undergo NIR imaging

PanitumumabBIOLOGICAL

Given IV

Panitumumab-IRDye800DRUG

Given IV

POINPOINT-IR9000

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1\) One of the following: 1. Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma 2. Cohort 4: Participants with suspected or confirmed diagnosis of vestibular schwannoma 2.) Planned surgical removal of the tumor as part of standard of care. This may include participants postchemotherapy, post-radiation, and/or participants who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection. 3\) Participant age ≥ 18 years. 4\) Participants or their designated advocates must be willing to and capable of providing informed consent and willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. Exclusion Criteria: 1. Received an investigational drug within 30 days prior to first dose of Panitumumab-IRDye800. 2. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease as determined by PI; or unstable angina within 6 months prior to enrollment. 3. History of infusion reactions to monoclonal antibody therapies 4. Pregnant or breastfeeding. 5. Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in males or greater than 460 ms in females). 6. Any of the following lab values: 1. Platelet count \< 75,000/mm3 2. TSH ≥ 13 micro International Units/mL. 3. Magnesium, potassium, or calcium \< each respective upper limit of normal 4. Serum creatinine \> 1.5 times upper limit of normal 7. Participants receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. 8. Participants with a history or evidence of interstitial pneumonitis or pulmonary fibrosis. 9. Participants not deemed by PI to be appropriate candidates for optimal resection of tumor based on location, involvement of eloquent brain, satellite lesions, or other factors not specifically listed here.

Locations (1)

Stanford University School of Medicine

Palo Alto, California, United States

RECRUITING

Outcomes

Primary Outcomes

Number of grade 2 or higher adverse events which have been determined to be clinically significant and definitely, probably, or possibly related to the study treatment, graded according to Common Terminology Criteria for Adverse Effects (CTCAE) v. 4.0

Descriptive statistical analysis of subject disposition, baseline characteristics, exposure to study drug, and adverse events will be performed. Descriptive statistics for continuous data will include mean, standard deviation, median, minimum, maximum, and inter-quartile values. Frequencies and percentages will be used to summarize categorical data.

Time frame: Up to 30 days

Secondary Outcomes

Tumor to background ratio (TBR)

TBR is defined as the fluorescence intensity of tumor tissue compared to that or normal surrounding tissue as determined by ex vivo pathological imaging. Will be analyzed with the individual specimen as the unit of analysis using the Wilcoxon signed rank test.

Time frame: 30 days from study treatment

Panitumumab Loading Dose

The fluorescence intensity of tissue obtained from patients undergoing surgery will be evaluated as an indicator of whether or not the loading dose of panitumumab is necessary to achieve an effective tumor-to-background ratio (TBR). The Fluorescence intensity of tissue will be assessed on the specimens collected on the day of surgery (Day 1-5 Post infusion), in group a vs group b, for Cohorts 1 and 2, in order to determine the tumor-to-background ratio (TBR). The outcome will be expressed as TBR by group and cohort. TBR will be reported as means +/- STD.

Time frame: 30 days

Optimal Timing of Surgical Procedure

The fluorescence intensity of tissue collected at surgery will be measured 1 to 5 days after infusion, and the outcome will be assessed as highest daily mean tumor-to-background ratio (TBR), with standard deviation. The tissue analysis to obtain the outcome data will occur within 1 year from surgery.

Time frame: 1 year

Central Contacts

Sandra Torres

CONTACT

(650) 723-5281 sandraet@stanford.edu

Data from ClinicalTrials.gov

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