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

Official Title: “A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia”

RATIONALE: Using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment.

PURPOSE: This laboratory study is using EF5 to evaluate tumor hypoxia in patients with high-grade soft tissue sarcoma or mouth cancer.

OBJECTIVES: - 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. - Determine the spatial relationships between EF5 binding and various tumor tissue markers, pathological processes, and serum plasminogen activator inhibitor-1 in these patients. - Correlate EF5 binding with Eppendorf electrode measurement and patient-related factors in these patients. - 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.

PROJECTED ACCRUAL: Approximately 120 patients (60 with soft tissue sarcoma and 60 with squamous cell carcinoma of the oral cavity) will be accrued for this study within 4 years.

Intervention(s) in this Clinical Trial

• Drug: EF5
• Other: laboratory biomarker analysis
• Other: pharmacological study

Primary Measures

• Biologically-relevant hypoxia by imaging and cellular analysis of EF5 binding
  • Safety Issue?: No
• Spatial relationships between EF5 binding and various tumor tissue markers, pathological processes, and serum plasminogen activator inhibitor-1
  • Safety Issue?: No
• Correlation of EF5 binding with Eppendorf electrode measurement and patient-related factors
  • Safety Issue?: No
• Adjusted and unadjusted associations between clinical outcome and optimal measures of EF5 binding, patient/tumor characteristics, and biological markers
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• ECOG 0-2
• 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
• No grade III or IV peripheral neuropathy
• No other medical condition that would preclude study compliance
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No chemotherapy within 3 months before planned surgery
• Preoperative radiotherapy allowed for STS
• No radiotherapy within 3 months before planned surgery
• No other concurrent investigational agents

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Pennsylvania Other

Overall Clinical Trial Officials and Contacts

Stephen Michael Hahn, MD Study Chair Abramson Cancer Center of the University of Pennsylvania  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00896961

Study ID Number: CDR0000078671

ClinicalTrials.gov Identifier: NCT00896961

Health Authority: United States: Food and Drug Administration

Clinical trial summary from the National Cancer Institute's PDQ® database