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

Not Applicable

Terminated

• 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: Drug: EF5; Other: diagnostic laboratory biomarker analysis; Other: pharmacological study

• Registration Number: NCT00896961
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study Start: 2001-08
• Primary Completion: 2007-09
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Observational (EF5)	diagnostic laboratory biomarker analysis	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.
Observational (EF5)	pharmacological study	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.
Observational (EF5)	EF5	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.

Primary Outcome Measures

Name	Time	Method
Time to locoregional recurrence in HNSCC patients	Time from study entry (EF5 administration) to locoregional recurrence, assessed up to 6 years
Time to distant metastasis in STS patients	Time from study entry (EF5 administration) to distant metastasis, assessed up to 6 years
How rapidly the STS recurred based on the original grade, time to recurrence and the degree of hypoxia in recurrent STS patients	Up to 6 years

Trial Locations

Locations (1)

Abramson Cancer Center of The University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States