EF5 Compared With Other Methods of Detecting Oxygen Levels in Tumor Cells of Patients With Head and Neck Cancer
This study has been completed.
Sponsor:
Duke University
Collaborator:
Information provided by (Responsible Party):
David M. Brizel, MD, Duke University
ClinicalTrials.gov Identifier:
NCT00049140
First received: November 12, 2002
Last updated: February 27, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: EF5 Other: bioluminescence Other: flow cytometry Other: immunohistochemistry staining method Procedure: biopsy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Pilot Study of the Relationship Between EF5 Uptake and Concentration of Oxygen-Related Metabolites in Head and Neck Cancer |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual [ Time Frame: One Year ] [ Designated as safety issue: No ]
- Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual [ Time Frame: One year ] [ Designated as safety issue: No ]
- Heterogeneity of glucose and lactate by bioluminescence imaging at completion of accrual [ Time Frame: One Year ] [ Designated as safety issue: No ]
- Spatial coordination as measured by EF5 binding at completion of accrual [ Time Frame: One Year ] [ Designated as safety issue: No ]
- Compare spatial coordination between the location of CA9 and hypoxia and/or lactate concentration at completion of accrual [ Time Frame: One year ] [ Designated as safety issue: No ]
| Enrollment: | 8 |
| Study Start Date: | August 2002 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EF5
This is a non randomised single arm pilot study.
|
Drug: EF5 Other: bioluminescence Other: flow cytometry Other: immunohistochemistry staining method Procedure: biopsy |
Detailed Description:
OBJECTIVES:
- Determine the distribution, degree, and intrapatient and interpatient heterogeneity of hypoxia, as measured by EF5 binding in tumor tissue, in patients with head and neck cancer.
- Determine the distribution and intrapatient and interpatient heterogeneity of CA9 expression, as measured immunohistochemically, in these patients.
- Determine the distribution, concentration, and intrapatient and interpatient heterogeneity of glucose and lactate, as measured by bioluminescence imaging, in these patients.
- Determine whether there is spatial coordination between concentrations of lactate and glucose and the location of tissue hypoxia in these patients.
- Determine whether there is spatial coordination between the location of CA9 with hypoxia and/or lactate concentrations in these patients.
OUTLINE: Patients receive EF5 IV over 1-2.5 hours on day 1. Within 24-55 hours after EF5 infusion, patients undergo surgery.
Tumor tissue samples are examined for EF5 binding by immunohistochemistry, bioluminescence imaging, and flow cytometry.
Patients are followed at 1 month and then for survival.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049140
Locations
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
Sponsors and Collaborators
Duke University
Investigators
| Study Chair: | David M. Brizel, MD | Duke University |
More Information
Additional Information:
No publications provided
| Responsible Party: | David M. Brizel, MD, Professor, Duke University |
| ClinicalTrials.gov Identifier: | NCT00049140 History of Changes |
| Other Study ID Numbers: | CDR0000257828, DUMC-3512-02-3, NCI-5929 |
| Study First Received: | November 12, 2002 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Duke University:
|
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 |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013