Overview
EF5 to Evaluate Tumor Hypoxia in Patients With High-Grade Soft Tissue Sarcoma or Mouth Cancer
Status:
Terminated
Terminated
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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 treatmentPhase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
National Cancer Institute (NCI)
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
- 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