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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Terminated
CT.gov ID
NCT00896961
Collaborator
(none)
120
Enrollment
1
Location
1
Arm

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: EF5
  • Other: diagnostic laboratory biomarker analysis
  • Other: pharmacological study
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. 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.

  2. Determine the spatial relationships between EF5 binding and various tumor tissue markers, pathological processes, and serum plasminogen activator inhibitor-1 in these patients.

  3. Correlate EF5 binding with Eppendorf electrode measurement and patient-related factors in these patients.

  4. 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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Does Hypoxia Predict Radiation/Surgical Tumor Response/A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia
Study Start Date :
Aug 1, 2001
Actual Primary Completion Date :
Sep 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Observational (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.

Drug: EF5

Other: diagnostic laboratory biomarker analysis

Other: pharmacological study
Other Names:
  • pharmacological studies

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to locoregional recurrence in HNSCC patients [Time from study entry (EF5 administration) to locoregional recurrence, assessed up to 6 years]

    2. Time to distant metastasis in STS patients [Time from study entry (EF5 administration) to distant metastasis, assessed up to 6 years]

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abramson Cancer Center of The University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Stephen Michael Hahn, Abramson Cancer Center of the University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00896961
    Other Study ID Numbers:
    • NCI-2012-02489
    • UPCC# 3300
    • CDR0000078671
    First Posted:
    May 12, 2009
    Last Update Posted:
    Jan 16, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Sarcoma
    Hypoxia

    Study Results

    No Results Posted as of Jan 16, 2013