Overview

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

Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
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 treatment
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
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