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Phase I/II 18F FPPRGD2 PET/CT Imaging of αvβ3 Integrins Expression as a Biomarker of Angiogenesis


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Male Breast Cancer, Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Adult Brain Tumor, Recurrent Basal Cell Carcinoma of the Lip, Recurrent Breast Cancer, Recurrent Colon Cancer, Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Recurrent Hypopharyngeal Cancer, Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Recurrent Laryngeal Cancer, Recurrent Lip and Oral Cavity Cancer, Recurrent Lymphoepithelioma of the Nasopharynx, Recurrent Lymphoepithelioma of the Oropharynx, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Nasopharyngeal Cancer, Recurrent Non-small Cell Lung Cancer, Recurrent Oropharyngeal Cancer, Recurrent Pancreatic Cancer, Recurrent Paranasal Sinus and Nasal Cavity Cancer, Recurrent Rectal Cancer, Recurrent Renal Cell Cancer, Recurrent Salivary Gland Cancer, Stage IIIA Breast Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Breast Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer, Stage IV Non-small Cell Lung Cancer, Stage IV Pancreatic Cancer, Stage IV Renal Cell Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVA Salivary Gland Cancer, Stage IVB Colon Cancer, Stage IVB Salivary Gland Cancer, Stage IVC Salivary Gland Cancer, Tongue Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I/II 18F FPPRGD2 PET/CT Imaging of αvβ3 Integrins Expression as a Biomarker of Angiogenesis


PRIMARY OBJECTIVES:

I. Evaluate 18F FPPRGD2 PET/CT for prediction and early assessment of response to
anti-angiogenesis therapy in patients with non-small cell lung cancer (NSCLC), breast
cancer, glioblastoma multiforme (GBM) and other cancers.

OUTLINE:

Patients undergo 18F FPPRGD2 PET/CT imaging at baseline, 1 week, and 6 weeks and 18F FDG
PET/CT at baseline and 6 weeks.

After completion of study imaging, patients are followed up at 12 months.


Inclusion Criteria:



- Provides written informed consent

- Diagnosed with advanced NSCLC, breast cancer, GBM or other cancers (such as head and
neck, colorectal, pancreatic, renal cancers); patients will undergo anti-angiogenesis
treatment

- Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria:

- Pregnant or nursing

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Change in maximum standard uptake values (SUVmax) on 18F FPPRGD2 and 18F FDG PET

Outcome Description:

Response to treatment is based on the change in PET uptake, change in CT tumor size, PET European Organization for Research and Treatment of Cancer (EORTC) response criteria, and CT Response Evaluation Criteria In Solid Tumors (RECIST) response criteria. Each of the four response criteria will be dichotomized into responding or non-responding to treatment. The Mann-Whitney test and logistic regression of response/non-response will be performed.

Outcome Time Frame:

From baseline up to 6 weeks

Safety Issue:

No

Principal Investigator

Sanjiv Gambhir

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

VARIMG0002

NCT ID:

NCT01806675

Start Date:

March 2013

Completion Date:

March 2019

Related Keywords:

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Male Breast Cancer
  • Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
  • Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
  • Recurrent Adult Brain Tumor
  • Recurrent Basal Cell Carcinoma of the Lip
  • Recurrent Breast Cancer
  • Recurrent Colon Cancer
  • Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Hypopharyngeal Cancer
  • Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Laryngeal Cancer
  • Recurrent Lip and Oral Cavity Cancer
  • Recurrent Lymphoepithelioma of the Nasopharynx
  • Recurrent Lymphoepithelioma of the Oropharynx
  • Recurrent Metastatic Squamous Neck Cancer With Occult Primary
  • Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
  • Recurrent Nasopharyngeal Cancer
  • Recurrent Non-Small Cell Lung Cancer
  • Recurrent Oropharyngeal Cancer
  • Recurrent Pancreatic Cancer
  • Recurrent Paranasal Sinus and Nasal Cavity Cancer
  • Recurrent Rectal Cancer
  • Recurrent Renal Cell Cancer
  • Recurrent Salivary Gland Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Stage IV Pancreatic Cancer
  • Stage IV Renal Cell Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVA Salivary Gland Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Salivary Gland Cancer
  • Stage IVC Salivary Gland Cancer
  • Tongue Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Brain Neoplasms
  • Breast Neoplasms
  • Carcinoma
  • Colonic Neoplasms
  • Laryngeal Neoplasms
  • Rectal Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Carcinoma, Squamous Cell
  • Carcinoma, Adenoid Cystic
  • Glioblastoma
  • Granuloma
  • Lung Neoplasms
  • Mouth Neoplasms
  • Pancreatic Neoplasms
  • Papilloma
  • Tongue Neoplasms
  • Oropharyngeal Neoplasms
  • Nasopharyngeal Neoplasms
  • Hypopharyngeal Neoplasms
  • Carcinoma, Mucoepidermoid
  • Esthesioneuroblastoma, Olfactory
  • Papilloma, Inverted
  • Gliosarcoma
  • Head and Neck Neoplasms
  • Neoplasms, Unknown Primary
  • Salivary Gland Neoplasms
  • Lip Neoplasms
  • Breast Neoplasms, Male

Name

Location

Stanford University Cancer InstituteStanford, California  94305