EF5 Compared With Other Methods of Detecting Oxygen Levels in Tumor Cells of Patients With Head and Neck Cancer

NCT00049140 | Completed Phase 2

• 3 other identifiers: CDR0000257828DUMC-3512-02-3NCI-5929
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors. PURPOSE: Phase II trial to compare diagnostic procedures using EF5 to that of other methods of detecting oxygen levels in tumor cells of patients who have head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

stage I squamous cell carcinoma of the hypopharynx; stage I squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the nasopharynx; stage I squamous cell carcinoma of the oropharynx; stage I squamous cell carcinoma of the paranasal sinus and nasal cavity; stage II squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the nasopharynx; stage II squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the paranasal sinus and nasal cavity; stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; stage I salivary gland cancer; stage II salivary gland cancer; stage III salivary gland cancer; stage IV salivary gland cancer; salivary gland squamous cell carcinoma

Outcome Measures

Primary Outcomes (5)

• Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual

  One Year

• Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual

  One year

• Heterogeneity of glucose and lactate by bioluminescence imaging at completion of accrual

  One Year

• Spatial coordination as measured by EF5 binding at completion of accrual

  One Year

• Compare spatial coordination between the location of CA9 and hypoxia and/or lactate concentration at completion of accrual

  One year

Study Arms (1)

EF5

EXPERIMENTAL

This is a non randomised single arm pilot study.

Drug: EF5; Other: bioluminescence; Other: flow cytometry; Other: immunohistochemistry staining method; Procedure: biopsy

Interventions

EF5 DRUG

EF5

bioluminescence OTHER

EF5

flow cytometry OTHER

EF5

immunohistochemistry staining method OTHER

EF5

biopsy PROCEDURE

EF5

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck * Clinically detectable disease by physical examination or radiographic studies * Scheduled to undergo surgical resection of tumor or radiotherapeutic treatment PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 mg/dL Renal * Creatinine no greater than 1.8 mg/dL Other * No allergy to IV contrast dye * No prior grade III or IV peripheral neuropathy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 week after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * Concurrent radiotherapy allowed Surgery * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• David M. Brizel, MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Salivary Gland Neoplasms

Interventions

Flow Cytometry; Immunohistochemistry; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Histocytochemistry; Histological Techniques; Immunologic Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• David M. Brizel, MD

  Duke University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: August 1, 2002
• Primary Completion: October 1, 2004
• Last Updated: July 25, 2014

Record last verified: 2013-02

Locations

US (1)