Trials / Terminated
TerminatedNCT00896961
EF5 to Evaluate Tumor Hypoxia in Patients With High-Grade Soft Tissue Sarcoma or Mouth Cancer
Does Hypoxia Predict Radiation/Surgical Tumor Response/A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
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 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.
Conditions
- Stage I Adult Soft Tissue Sarcoma
- Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage II Adult Soft Tissue Sarcoma
- Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage III Adult Soft Tissue Sarcoma
- Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EF5 | |
| OTHER | diagnostic laboratory biomarker analysis | |
| OTHER | pharmacological study |
Timeline
- Start date
- 2001-08-01
- Primary completion
- 2007-09-01
- First posted
- 2009-05-12
- Last updated
- 2013-01-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00896961. Inclusion in this directory is not an endorsement.