Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Near-Infrared Fluorescence Imaging
  Undergo NIR imaging
• Биопрепарат Panitumumab
  Given IV
• Препарат Panitumumab-IRDye800
  Given IV
• Устройство 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").

Первичные конечные точки

• 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 [Срок оценки: Up to 30 days]

Вторичные конечные точки (3)

• Tumor to background ratio (TBR) [Срок оценки: 30 days from study treatment]
• Panitumumab Loading Dose [Срок оценки: 30 days]
• Optimal Timing of Surgical Procedure [Срок оценки: 1 year]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Stanford University School of Medicine — Palo Alto

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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