Spots Global Cancer Trial Database for EF5 to Evaluate Tumor Hypoxia in Patients With High-Grade Soft Tissue Sarcoma or Mouth Cancer

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Trial Identification

Brief Title: EF5 to Evaluate Tumor Hypoxia in Patients With High-Grade Soft Tissue Sarcoma or Mouth Cancer

Official Title: Does Hypoxia Predict Radiation/Surgical Tumor Response/A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia

Study ID: NCT00896961

Conditions

Stage I Adult Soft Tissue Sarcoma

Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage II Adult Soft Tissue Sarcoma

Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage III Adult Soft Tissue Sarcoma

Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity

Interventions

EF5

diagnostic laboratory biomarker analysis

pharmacological study

Study Description

Brief Summary: This laboratory study is using EF5 to evaluate tumor hypoxia in patients with high-grade soft tissue sarcoma or mouth cancer. Using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment

Detailed Description: PRIMARY OBJECTIVES: I. Determine biologically-relevant hypoxia by imaging and cellular analysis of EF5 binding in patients with high-grade soft tissue sarcoma of the trunk or extremity or squamous cell carcinoma of the oral cavity. II. Determine the spatial relationships between EF5 binding and various tumor tissue markers, pathological processes, and serum plasminogen activator inhibitor-1 in these patients. III. Correlate EF5 binding with Eppendorf electrode measurement and patient-related factors in these patients. IV. Determine the adjusted and unadjusted associations between clinical outcome and optimal measures of EF5 binding, patient/tumor characteristics, and biological markers in these patients. OUTLINE: Approximately 24-48 hours prior to surgical resection or biopsy, patients receive EF5 IV over no more than 2½ hours. Tissue samples are analyzed by immunohistochemistry for EF5 binding. Blood samples are analyzed for genetic markers and cytokines associated with hypoxia and EF5 concentration.