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

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ClinicalTrials.gov Identifier: NCT00896961
Recruitment Status : Terminated (Administratively complete.)
First Posted : May 12, 2009
Last Update Posted : January 16, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

May 9, 2009
May 12, 2009
January 16, 2013
August 2001
September 2007   (Final data collection date for primary outcome measure)
  • Time to locoregional recurrence in HNSCC patients [ Time Frame: Time from study entry (EF5 administration) to locoregional recurrence, assessed up to 6 years ]
  • Time to distant metastasis in STS patients [ Time Frame: 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 [ Time Frame: Up to 6 years ]
  • Biologically-relevant hypoxia by imaging and cellular analysis of EF5 binding
  • Spatial relationships between EF5 binding and various tumor tissue markers, pathological processes, and serum plasminogen activator inhibitor-1
  • Correlation of EF5 binding with Eppendorf electrode measurement and patient-related factors
  • Adjusted and unadjusted associations between clinical outcome and optimal measures of EF5 binding, patient/tumor characteristics, and biological markers
Complete list of historical versions of study NCT00896961 on ClinicalTrials.gov Archive Site
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EF5 to Evaluate Tumor Hypoxia in Patients With High-Grade Soft Tissue Sarcoma or Mouth Cancer
Does Hypoxia Predict Radiation/Surgical Tumor Response/A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia
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

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
  • 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
  • Drug: EF5
  • Other: diagnostic laboratory biomarker analysis
  • Other: pharmacological study
    Other Name: pharmacological studies
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.
Interventions:
  • Drug: EF5
  • Other: diagnostic laboratory biomarker analysis
  • Other: pharmacological study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
Same as current
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September 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00896961
NCI-2012-02489
UPCC# 3300
CDR0000078671 ( Registry Identifier: PDQ (Physician Data Query) )
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National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Stephen Michael Hahn Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP