Status:
TERMINATED
EF5 to Evaluate Tumor Hypoxia in Patients With High-Grade Soft Tissue Sarcoma or Mouth Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Stage I Adult Soft Tissue Sarcoma
Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 ce...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00896961
Start Date
August 1 2001
Last Update
January 16 2013
Active Locations (1)
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1
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104