Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Stanford University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Malignant Brain Neoplasm; Malignant Glioma

Treatments: Drug: Panitumumab-IRDye800; Procedure: Near-Infrared Fluorescence Imaging; Device: POINPOINT-IR9000; Biological: Panitumumab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03510208

BRNCNS0009 (Other Identifier)

IRB-43179

R01CA190306 (U.S. NIH Grant/Contract)

NCI-2018-00536 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

46 participants in 4 patient groups

Cohort 1 -50mg panitumumab-IRDye800

Experimental group

Description:

A panitumumab-IRDye800 dose of 50mg (Cohort 1) with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery. Participants then undergo NIR imaging during standard of care surgery 1-5 days after receiving panitumumab-IRDye800.

Treatment:

Biological: Panitumumab

Device: POINPOINT-IR9000

Drug: Panitumumab-IRDye800

Procedure: Near-Infrared Fluorescence Imaging

Cohort 2 -100mg panitumumab-IRDye800

Experimental group

Description:

A panitumumab-IRDye800 dose of 100mg (Cohort 2) with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery. Participants then undergo NIR imaging during standard of care surgery 1-5 days after receiving panitumumab-IRDye800.

Treatment:

Biological: Panitumumab

Device: POINPOINT-IR9000

Drug: Panitumumab-IRDye800

Procedure: Near-Infrared Fluorescence Imaging

Cohort 3 -100mg panitumumab-IRDye800

Experimental group

Description:

Cohort 3 dose will be determined based on Cohort 1 and Cohort 2, with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery

Treatment:

Biological: Panitumumab

Device: POINPOINT-IR9000

Drug: Panitumumab-IRDye800

Procedure: Near-Infrared Fluorescence Imaging

Cohort 4

Experimental group

Description:

Cohort 4 will enroll 24 participants with vestibular schwannomas at the optimal dose of 100mg, as determined by the research team based on data analysis from the first two cohorts.

Treatment:

Biological: Panitumumab

Device: POINPOINT-IR9000

Drug: Panitumumab-IRDye800

Procedure: Near-Infrared Fluorescence Imaging