CompletedPhase 2

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

United States8 participantsStarted 2002-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: One Year

Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual

Timeframe: One year

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

Timeframe: One Year

Spatial coordination as measured by EF5 binding at completion of accrual

Timeframe: One Year

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

Timeframe: One year

Trial details

NCT IDNCT00049140

SponsorDavid M. Brizel, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2004-10

View on ClinicalTrials.gov More Head and Neck Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: One Year

Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual

Timeframe: One year

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

Timeframe: One Year

Spatial coordination as measured by EF5 binding at completion of accrual

Timeframe: One Year

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

Timeframe: One year