Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. 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.
2. Determine the spatial relationships between EF5 binding and various tumor tissue markers, pathological processes, and serum plasminogen activator inhibitor-1 in these patients.
3. Correlate EF5 binding with Eppendorf electrode measurement and patient-related factors in these patients.
4. Determine the adjusted and unadjusted associations between clinical outcome and optimal measures of EF5 binding, patient/tumor characteristics, and biological markers in these patients.

Entry Criteria

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

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

Patient Characteristics:

• ECOG 0-2
• WBC at least 2,000/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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.

Outcomes

Biologically-relevant hypoxia by imaging and cellular analysis of EF5 binding
Spatial relationships between EF5 binding and various tumor tissue markers, pathological processes, and serum plasminogen activator inhibitor-1
Correlation of EF5 binding with Eppendorf electrode measurement and patient-related factors
Adjusted and unadjusted associations between clinical outcome and optimal measures of EF5 binding, patient/tumor characteristics, and biological markers

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.

Trial Contact Information

Trial Lead Organizations

Abramson Cancer Center of the University of Pennsylvania

Stephen Michael Hahn, MD, Protocol chair		Ph: 215-662-7296 Email: hahn@xrt.upenn.edu

Registry Information
Official Title		A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia
Trial Start Date		2001-08-18
Registered in ClinicalTrials.gov		NCT00896961
Date Submitted to PDQ		2001-09-11
Information Last Verified		2007-09-16
NCI Grant/Contract Number		CA16520

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