Panitumumab-IRDye800 dans la détection du cancer chez les participants atteints d'un cancer du poumon pendant la chirurgie
Une étude de phase I/II évaluant l'innocuité et la pharmacocinétique du panitumumab-IRDye800 en tant qu'agent d'imagerie optique pour détecter le cancer du poumon lors d'interventions chirurgicales
This phase I/II trial studies the best dose and timing of panitumumab-IRDye800 in detecting cancer in participants with lung cancer during the surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with lung cancer.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
PRIMARY OBJECTIVES:
I. To determine the optimal dose and timing of panitumumab IRDye800 infusion for identifying lung cancer compared to surrounding normal tissue in the ex vivo setting as measured by tumor to background ratio.
SECONDARY OBJECTIVES:
I. Determine the safety and tolerability of the panitumumab IRDye800 as an imaging agent in subjects undergoing resection of lung cancer.
II. Determine whether the primary lung tumor or positive lymph nodes can be detected by near-infrared (NIR) fluorescence imaging with panitumumab IRDye800 but not by white light imaging.
OUTLINE: This is a phase I, dose-escalation study of panitumumab-IRDye800 followed by a phase II study.
Participants receive panitumumab- IRDye800 intravenously (IV) over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.
After completion of study treatment, participants are followed up for up to 30 days.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Natalie Lui
- Numéro de téléphone: 650-721-2086
- E-mail: natalielui@stanford.edu
Lieux d'étude
-
-
California
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Palo Alto, California, États-Unis, 94304
- Recrutement
- Stanford University, School of Medicine
-
Chercheur principal:
- Natalie Lui
-
Contact:
- Natalie Lui
- Numéro de téléphone: 650-721-2086
- E-mail: natalielui@stanford.edu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients with lung nodule or mass concerning for malignancy, either primary lung cancer or lung metastases, whether or not it is biopsy-proven
- Patients scheduled to undergo planned standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent for lung cancer
- Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2
- Hemoglobin ≥ 9 gm/dL
- White blood cell count > 3000/mm^3
- Platelet count ≥ 100,000/mm^3
- Serum creatinine ≤ 1.5 times upper reference range
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
- Magnesium or potassium lower than the normal institutional values
- Subjects receiving class IA (quinidine, procanamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
- Prisoners, institutionalized individuals, and patients unable to consent for themselves
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Diagnostic (panitumumab-IRDye800, surgery, NIR)
Participants receive panitumumab- IRDye800 IV over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days. |
Undergo surgery Undergo imaging
Autres noms:
Given IV
Autres noms:
Correlative studies
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Tumor to background ratio (TBR), measured in ex vivo tissues
Délai: Up to 1 year
|
The TBR is defined as the near-infrared fluorescence signal of tumor or lymph node tissue compared to normal adjacent tissue measured in ex vivo tissues. Outcomes will be reported as the TBR (mean) and standard deviation for each dose group and timing group (1-2 days or 3-5 days prior to surgery). |
Up to 1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Nombre d'EI de grade 2 ou plus déterminés comme étant cliniquement significatifs et définitivement, probablement ou possiblement liés au médicament à l'étude
Délai: Jusqu'à 30 jours
|
Jusqu'à 30 jours
|
|
|
Metastatic lesion detection by Panitumumab-IRDye800 versus standard assessments
Délai: Up to 1 year
|
Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify metastatic lesions. Outcomes will be reported as the number of metastatic lesions detected by both near-infrared fluorescence imaging and histopathology, and each method alone. |
Up to 1 year
|
|
Tumor-positive lymph node detection by Panitumumab-IRDye800 versus standard assessments
Délai: Up to 1 year
|
Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify tumor-positive lymph nodes. Outcomes will be reported as the number of tumor-positive lymph nodes detected by both near-infrared fluorescence imaging and histopathology, and each method alone. |
Up to 1 year
|
|
Residual disease detection by Panitumumab-IRDye800 versus standard assessments
Délai: Up to 1 year
|
Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify residual disease at resection margins. Outcomes will be reported as the number of positive-margins detected by both near-infrared fluorescence imaging and histopathology, and each method alone. |
Up to 1 year
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Natalie Lui, Stanford University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB-41302
- NCI-2018-00494 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- LUN0099 (Autre identifiant: OnCore)
Informations sur les médicaments et les dispositifs, documents d'étude
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