Clinical trial NCT00896961: EF5 to Evaluate Tumor Hypoxia in Patients With High-Grade Soft Tissue Sarcoma or Mouth Cancer
Official title: Does Hypoxia Predict Radiation/Surgical Tumor Response/A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-05-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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 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.

Eligibility 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

Primary outcomes:
measure: Time to locoregional recurrence in HNSCC patients
timeFrame: Time from study entry (EF5 administration) to locoregional recurrence, assessed up to 6 years
measure: Time to distant metastasis in STS patients
timeFrame: Time from study entry (EF5 administration) to distant metastasis, assessed up to 6 years
measure: How rapidly the STS recurred based on the original grade, time to recurrence and the degree of hypoxia in recurrent STS patients
timeFrame: Up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of The University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Stephen Michael Hahn
role: PRINCIPAL_INVESTIGATOR
References: