Health TrialsbyHealthPanel

Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

ConditionsMalignant Brain NeoplasmMalignant Glioma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma

Cohort 4: Participants with suspected or confirmed diagnosis of vestibular schwannoma

Disqualifiers

Received an investigational drug within 30 days prior to first dose of Panitumumab-IRDye800.

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.

History of infusion reactions to monoclonal antibody therapies

Pregnant or breastfeeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Near-Infrared Fluorescence Imaging

    Procedure/Surgery

    Undergo NIR imaging

  • Panitumumab

    Biological/Vaccine

    Given IV

  • Panitumumab-IRDye800

    Drug

    Given IV

  • POINPOINT-IR9000

    Device

    Intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during surgery and/or on ex-vivo resected tissues in the surgery suite ("back table").

Treatment groups

46 Participants
are divided into 4 treatment groups
Group A: Cohort 1 -50mg panitumumab-IRDye800Experimental treatment 4 interventions
Group B: Cohort 2 -100mg panitumumab-IRDye800Experimental treatment 4 interventions
Group C: Cohort 3 -100mg panitumumab-IRDye800Experimental treatment 4 interventions
Group D: Cohort 4Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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