Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery

NCT02855086 | Terminated Phase 1 Results DMC FDA Drug

• 4 other identifiers: IRB-37595NCI-2016-01165BRNCNS0008P30CA124435
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase 1-2 trial that evaluates the best dose of cetuximab-IRDye 800CW and how well it works in detecting tumors in patients with malignant glioma who are undergoing surgery. Cetuximab-IRDye 800CW is an optical imaging agent that may help detect tumor cells when a special camera is used.

Conditions

Brain Neoplasm; Malignant Glioma

Outcome Measures

Primary Outcomes (1)

• Tumor to Background Ratio (TBR)

  Tumor to background ratios (TBR) will be generated from still images by comparing the relative fluorescence of normal and tumor tissue. The average fluorescence will be compared to the average fluorescence of the surrounding tissue using the paired student's T test for each specimen.

  1 day

Secondary Outcomes (1)

• Incidence of Adverse Events

  Up to 30 days

Study Arms (2)

50 mg cetuximab-IRDye 800

EXPERIMENTAL

Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0. All patients undergo standard of care surgical resection of tumor on days 2 to 5.

Biological: Cetuximab; Drug: Cetuximab-IRDye 800CW; Procedure: Tumor resection

100 mg cetuximab-IRDye 800

EXPERIMENTAL

Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0. All patients undergo standard of care surgical resection of tumor on days 2 to 5.

Biological: Cetuximab; Drug: Cetuximab-IRDye 800CW; Procedure: Tumor resection

Interventions

Cetuximab BIOLOGICAL

Administered intravenously (IV)

Also known as: Erbitux, Chimeric Anti-epidermal growth factor receptor (EGFR0 monoclonal antibody, Chimeric Monoclonal Antibody (MoAb) C225, IMC-C225

100 mg cetuximab-IRDye 800; 50 mg cetuximab-IRDye 800

Cetuximab-IRDye 800CW DRUG

Administered intravenously (IV)

Also known as: Cetuximab-IRDye 800, Cetuximab-IRDye800, Cetuximab-IRDye800CW

100 mg cetuximab-IRDye 800; 50 mg cetuximab-IRDye 800

Tumor resection PROCEDURE

Standard of care treatment

Also known as: Conventional Surgery

100 mg cetuximab-IRDye 800; 50 mg cetuximab-IRDye 800

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected brain tumors to undergo removal (surgical resection) as standard of care, as assessed by the operating surgeon
• Life expectancy of \> 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/mm³
• Magnesium, potassium and calcium \> the lower limit of normal per institution normal lab values
• Thyroid-stimulating hormone (TSH) \< 13 micro international units/mL

You may not qualify if:

• Received an investigational drug within 30 days prior to first dose of cetuximab IRDye800
• Within 6 months prior to enrollment, myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina
• History of infusion reactions to cetuximab or other monoclonal antibody therapies
• Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
• Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
• Pregnant or breastfeeding

Sponsors & Collaborators

• Eben Rosenthal: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Interventions

Cetuximab; Antibodies, Monoclonal; Transurethral Resection of Bladder

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Gordon Li, MD, Associate Professor of Neurosurgery
• Organization: Stanford University Medical Center

gordonli@stanford.edu

650-721-1020

Study Officials

• Gordon Li, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Eben Rosenthal, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 4, 2016
• Study Start: October 1, 2016
• Primary Completion: November 8, 2016
• Study Completion: November 22, 2016
• Last Updated: March 31, 2020
• Results First Posted: May 14, 2018

Record last verified: 2020-03

Locations

US (1)