Does Hypoxia Predict Radiation/Surgical Tumor Response/A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia
Overview
- Phase
- Not Applicable
- Intervention
- EF5
- Conditions
- Stage I Adult Soft Tissue Sarcoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Time to locoregional recurrence in HNSCC patients
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed high-grade soft tissue sarcoma (STS) of the trunk or extremity or squamous cell carcinoma of the oral cavity for which surgical biopsy or resection is standard initial therapy
- •Clinical imaging of mass that is likely to be STS or squamous cell carcinoma of the head and neck allowed if surgery is indicated prior to definitive diagnosis
- •Planned resection and standard oncologic treatment
- •No known distant metastatic disease
- •WBC at least 2,000/mm\^3
- •Platelet count at least 100,000/mm\^3
- •Bilirubin less than 2.0 mg/dL
- •Creatinine less than 2.0 mg/dL OR creatinine clearance at least 50 mL/min
- •No significant cardiac condition that would preclude study compliance
- •Weight no greater than 130 kg
Exclusion Criteria
- Not provided
Arms & Interventions
Observational (EF5)
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.
Intervention: EF5
Observational (EF5)
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.
Intervention: diagnostic laboratory biomarker analysis
Observational (EF5)
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.
Intervention: pharmacological study
Outcomes
Primary Outcomes
Time to locoregional recurrence in HNSCC patients
Time Frame: Time from study entry (EF5 administration) to locoregional recurrence, assessed up to 6 years
Time to distant metastasis in STS patients
Time Frame: Time from study entry (EF5 administration) to distant metastasis, assessed up to 6 years
How rapidly the STS recurred based on the original grade, time to recurrence and the degree of hypoxia in recurrent STS patients
Time Frame: Up to 6 years