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

National Cancer Institute (NCI)

Status

Terminated

Conditions

Stage II Adult Soft Tissue Sarcoma

Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage III Adult Soft Tissue Sarcoma

Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage I Adult Soft Tissue Sarcoma

Treatments

Other: pharmacological study

Other: diagnostic laboratory biomarker analysis

Drug: EF5

Study type

Interventional

Funder types

NIH

Identifiers

NCT00896961

UPCC# 3300

CDR0000078671 (Registry Identifier)

NCI-2012-02489

Details and patient eligibility

About

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

Full 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 cell carcinoma of the oral cavity.

II. Determine the spatial relationships between EF5 binding and various tumor tissue markers, pathological processes, and serum plasminogen activator inhibitor-1 in these patients.

III. Correlate EF5 binding with Eppendorf electrode measurement and patient-related factors in these patients.

IV. 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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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