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


N/A
18 Years
N/A
Not Enrolling
Both
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

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Time to locoregional recurrence in HNSCC patients

Outcome Time Frame:

Time from study entry (EF5 administration) to locoregional recurrence, assessed up to 6 years

Safety Issue:

No

Principal Investigator

Stephen Michael Hahn

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02489

NCT ID:

NCT00896961

Start Date:

August 2001

Completion Date:

Related Keywords:

  • 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
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Sarcoma
  • Anoxia

Name

Location
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283