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Trial record 7 of 15 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | Brain Tumor | United States | Phase Early Phase 1, 1, 2 | Start date from 02/15/2018 to 06/11/2018

Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT03510208
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Eben Rosenthal, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Brain Neoplasm Malignant Glioma Procedure: Near-Infrared Fluorescence Imaging Biological: Panitumumab Drug: Panitumumab-IRDye800 Other: Pharmacokinetic Study Procedure: Surgical Procedure Phase 1 Phase 2

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. Participants are assigned to 1 of 2 groups.

GROUP A (Cohorts 1a, 2a, & 3): Participants receive panitumumab intravenously (IV) over 60 minutes on day 0, and following a 15-minute observation period, receive panitumumab-IRDye800 IV over 60 minutes. Participants then undergo near-infrared fluorescence (NIR) imaging during standard of care surgery 1-5 days after receiving panitumumab-IRDye800.

GROUP B (Cohorts 1b and 2b): Participants receive panitumumab-IRDye800 IV over 60 minutes on day 0. Participants then undergo NIR imaging as in Group A.

After completion of study treatment, participants are followed up on day 15 and then again on day 30.


Study Type : Interventional
Estimated Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : May 14, 2021
Estimated Study Completion Date : May 14, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

Arm Intervention/treatment
Experimental: Group A (panitumumab, panitumumab-IRDye800, NIR)
Participants receive panitumumab IV over 60 minutes on day 0, and following a 15-minute observation period, receive panitumumab-IRDye800 IV over 60 minutes. Participants then undergo NIR imaging during standard of care surgery 1-5 days after receiving panitumumab-IRDye800.
Procedure: Near-Infrared Fluorescence Imaging
Undergo NIR imaging
Other Names:
  • NIR Fluorescence Imaging
  • NIR Optical Imaging

Biological: Panitumumab
Given IV
Other Names:
  • ABX-EGF
  • ABX-EGF Monoclonal Antibody
  • ABX-EGF, Clone E7.6.3
  • MoAb ABX-EGF
  • Monoclonal Antibody ABX-EGF
  • Vectibix

Drug: Panitumumab-IRDye800
Given IV
Other Names:
  • Panitumumab IRDye 800
  • RDye800-Panitumumab Conjugate

Other: Pharmacokinetic Study
Correlative studies
Other Names:
  • PHARMACOKINETIC
  • PK Study

Procedure: Surgical Procedure
Undergo surgery
Other Names:
  • Operation
  • surgery
  • Surgical
  • Surgical Interventions
  • Surgical Procedures

Experimental: Group B (panitumumab-IRDye800, NIR)
Participants receive panitumumab-IRDye800 IV over 60 minutes on day 0. Participants then undergo NIR imaging as in Group A.
Procedure: Near-Infrared Fluorescence Imaging
Undergo NIR imaging
Other Names:
  • NIR Fluorescence Imaging
  • NIR Optical Imaging

Drug: Panitumumab-IRDye800
Given IV
Other Names:
  • Panitumumab IRDye 800
  • RDye800-Panitumumab Conjugate

Other: Pharmacokinetic Study
Correlative studies
Other Names:
  • PHARMACOKINETIC
  • PK Study

Procedure: Surgical Procedure
Undergo surgery
Other Names:
  • Operation
  • surgery
  • Surgical
  • Surgical Interventions
  • Surgical Procedures




Primary Outcome Measures :
  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 [ Time Frame: Up to 30 days ]
    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.


Secondary Outcome Measures :
  1. Tumor to background ratio (TBR) [ Time Frame: 30 days from study treatment ]
    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.

  2. Panitumumab Loading Dose [ Time Frame: 30 days ]
    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.

  3. Optimal Timing of Surgical Procedure [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with suspected brain tumors undergoing surgical removal as their standard of care will be eligible; these may include subjects' status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are assessed to be candidates for resection
  • Subjects must be eligible for resection as determined by the operating surgeon
  • Planned standard of care surgery
  • Life expectancy of more than 12 weeks
  • Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1
  • Hemoglobin ≥ 9 gm/dL
  • Platelet count ≥ 100,000/mm^3
  • White blood cell count > 3000/mm^3

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; or unstable angina within 6 months prior to enrollment
  • History of infusion reactions to monoclonal antibody therapies
  • Pregnant or breastfeeding
  • Evidence of corrected QT (QTc) prolongation on pre-treatment electrocardiography (ECG) (greater than 440ms in males or greater than 460ms in females)
  • Thyroid-stimulating hormone (TSH) ≥ 13 micro international units/mL
  • Magnesium, potassium and calcium < the lower limit of normal per institution normal lab values
  • Serum creatinine > 1.5 times upper reference range
  • Other lab values that in the opinion of the primary surgeon would prevent surgical resection
  • Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  • Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Subjects not deemed 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03510208


Contacts
Contact: Stefania Chirita 650-723-1423 schirita@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Stefania Chirita    650-723-1423    schirita@stanford.edu   
Principal Investigator: Gordon Li         
Sponsors and Collaborators
Eben Rosenthal
Investigators
Principal Investigator: Gordon Li Stanford University

Responsible Party: Eben Rosenthal, Professor of Otolaryngology, Stanford University
ClinicalTrials.gov Identifier: NCT03510208     History of Changes
Other Study ID Numbers: BRNCNS0009
NCI-2018-00536 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
BRNCNS0009 ( Other Identifier: Stanford Cancer Institute Palo Alto )
43179 ( Other Identifier: Stanford IRB )
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Neoplasms
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Glioma
Central Nervous System Diseases
Nervous System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs