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

Stage III Adult Soft Tissue Sarcoma Clinical Trial

Official title:

Does Hypoxia Predict Radiation/Surgical Tumor Response/A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00896961
• Other study ID #: NCI-2012-02489
• Secondary ID: UPCC# 3300CDR000
• Status: Terminated
• Phase: N/A
• First received: May 9, 2009
• Last updated: January 15, 2013
• Start date: August 2001

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Sarcoma
• 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

Intervention

Drug:
• EF5

Other:
• diagnostic laboratory biomarker analysis

• pharmacological study

Locations

Country	Name	City	State
United States	Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to locoregional recurrence in HNSCC patients		Time from study entry (EF5 administration) to locoregional recurrence, assessed up to 6 years	No
Primary	Time to distant metastasis in STS patients		Time from study entry (EF5 administration) to distant metastasis, assessed up to 6 years	No
Primary	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	No