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

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00896961
First received: May 9, 2009
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Does Hypoxia Predict Radiation/Surgical Tumor Response/A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to locoregional recurrence in HNSCC patients [ Time Frame: Time from study entry (EF5 administration) to locoregional recurrence, assessed up to 6 years ] [ Designated as safety issue: No ]
  • Time to distant metastasis in STS patients [ Time Frame: Time from study entry (EF5 administration) to distant metastasis, assessed up to 6 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: August 2001
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: pharmacological studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896961

Locations
United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Principal Investigator: Stephen Michael Hahn Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00896961     History of Changes
Other Study ID Numbers: NCI-2012-02489, UPCC# 3300, CDR0000078671
Study First Received: May 9, 2009
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Sarcoma
Anoxia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Connective and Soft Tissue
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014