Menu
Recruiting NCT03510208

Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Phase I / Phase II Interventional Malignant Brain Neoplasm Malignant Glioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Near-Infrared Fluorescence Imaging, Panitumumab, Panitumumab-IRDye800, POINPOINT-IR9000.
Who it may be relevant to
Registry conditions: Malignant Brain Neoplasm, Malignant Glioma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase I/II, Open-Label Study Evaluating the Efficacy and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures

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.

Detailed description

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.

Interventions

  • Procedure Near-Infrared Fluorescence Imaging
    Undergo NIR imaging
  • Biological Panitumumab
    Given IV
  • Drug Panitumumab-IRDye800
    Given IV
  • Device POINPOINT-IR9000
    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").

Primary outcome measures

  • 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 [Time frame: Up to 30 days]
Secondary outcome measures (3)
  • Tumor to background ratio (TBR) [Time frame: 30 days from study treatment]
  • Panitumumab Loading Dose [Time frame: 30 days]
  • Optimal Timing of Surgical Procedure [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

1\) One of the following:

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

  • 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.
  • Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in males or greater than 460 ms in females).
  • Any of the following lab values:
  • Platelet count < 75,000/mm3
  • TSH ≥ 13 micro International Units/mL.
  • Magnesium, potassium, or calcium < each respective upper limit of normal
  • Serum creatinine > 1.5 times upper limit of normal
  • Participants receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
  • Participants with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Stanford University School of Medicine — Palo Alto

Identifiers

NCT: NCT03510208 · IRB-43179 · NCI-2018-00536 · BRNCNS0009 · R01CA190306

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗