RATIONALE: Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors.

PURPOSE: This phase I trial is studying how well EF5 works in detecting the presence of oxygen in tumor cells in patients with solid tumors that can be biopsied or removed by surgery.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: EF5  Procedure: conventional surgery  Procedure: diagnostic test  Procedure: fluorescent antibody technique  Procedure: surgery	Phase I

Further Study Details: 

OBJECTIVES:

• Determine the optimal dose of etanidazole derivative EF5 that is safely tolerated and provides optimal signal-to-noise ratio in patients with solid tumors.
• Determine the toxic effects of EF5 in this patient population.
• Determine the pharmacokinetics of EF5 in this patient population.
• Determine the dose of EF5 that provides a mean signal-to-noise ratio (maximum binding in anoxia to minimum binding) of 75.
• Determine the relationship between tumor oxygenation by EF5 binding and needle electrode measurements.
• Compare the levels of EF5 binding in regions of low and high blood flow.

OUTLINE: This is a dose-escalation study.

Patients receive etanidazole derivative EF5 IV over 1-2 hours beginning approximately 24 hours prior to surgery. Tumors are then resected or biopsied after Eppendorf needle electrode measurements.

Cohorts of 6 patients receive escalating doses of EF5 until the maximum tolerated dose (MTD) or optimal dose is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose-limiting toxicity. The optimal dose is defined as the dose level at or below the MTD and results in a signal-to-noise ratio of 75 or greater. Thirty additional patients are treated at the optimal dose.

Patients are followed at 30-45 days post EF5 infusion.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed tumor or highly suspicious cancerous mass based on imaging and clinical signs but not indicative of a direct biopsy/cellular diagnosis preceding surgery
• Must have a clinical condition or physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 2,000/mm^3
• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin less than 2.0 mg/dL

Renal:

• Creatinine less than 2.0 mg/dL OR
• Creatinine clearance greater than 50 mL/min

Cardiovascular:

• No significant cardiac disease that would preclude the safe use of general anesthesia

Pulmonary:

• No significant pulmonary disease that would preclude the safe use of general anesthesia

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 1 month after study
• No history of grade III or IV peripheral neuropathy

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Pennsylvania
      Abramson Cancer Center at the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting

Study chairs or principal investigators

W. Gillies McKenna, MD, PhD,  Study Chair,  University of Pennsylvania Cancer Center   

Study ID Numbers:  CDR0000066191; UPCC-7597; NCI-T97-0045; NCT00003282
Record last reviewed:  July 2003
Last Updated:  March 3, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003282
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08