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

NCT00896961 | Terminated

• 3 other identifiers: NCI-2012-02489UPCC# 3300CDR0000078671
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Observational (EF5)

EXPERIMENTAL

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.

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

Interventions

EF5 DRUG

Observational (EF5)

diagnostic laboratory biomarker analysis OTHER

Observational (EF5)

pharmacological study OTHER

Also known as: pharmacological studies

Observational (EF5)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Stephen Michael Hahn

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: August 1, 2001
• Primary Completion: September 1, 2007
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

US (1)