RATIONALE: Diagnostic procedures using EF5 to detect oxygen level and blood vessels in tumor cells may help to improve the way photodynamic therapy is given.

PURPOSE: Clinical trial to study the effectiveness of EF5 in detecting oxygen level and blood vessels in tumor cells of patients who are undergoing photodynamic therapy for intraperitoneal or pleural cancer.

Condition	Treatment or Intervention
malignant ascites peritoneal cavity cancer advanced malignant mesothelioma localized malignant mesothelioma recurrent malignant mesothelioma	Drug: EF5  Procedure: diagnostic test  Procedure: fluorescent antibody technique  Procedure: immunohistochemistry

Further Study Details: 

OBJECTIVES:

• Determine the level of hypoxia through etanidazole derivative EF5 binding in patients with intraperitoneal or pleural malignancies treated with photodynamic therapy.
• Determine the microvascular density in this patient population.
• Determine the relationships between levels of hypoxia, measures of microvascular density, and photosensitizer levels in this patient population.
• Correlate hypoxia and photosensitizer levels with clinical outcome in this patient population.
• Determine the toxic effects of EF5 in this patient population.

OUTLINE: This is a multicenter study.

Patients receive etanidazole derivative EF5 IV over 1-2 hours. Approximately 48 hours after EF5 administration, patients with intraperitoneal tumors undergo surgical resection. Patients with pleural tumors undergo surgical resection approximately 24 hours after EF5 administration. Tumors are then analyzed for EF5 binding and microvascular density by immunohistochemistry and fluorescent antibody techniques.

Patients are followed at 2 weeks and at 30-45 days post EF5 infusion.

PROJECTED ACCRUAL: A total of 80 patients (50 with intraperitoneal malignancy and 30 with pleural malignancy) will be accrued for this study within 2.5 years. Patients are stratified by disease (intraperitoneal malignancy vs pleural malignancy).

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed intraperitoneal or pleural malignancy
• Currently enrolled on 1 of 3 photodynamic therapy trials (UPCC-2997, UPCC-4997, or UPCC-05503)
• Plan to undergo surgery for treatment on one of these protocols
• Patients with suspected recurrent disease undergoing surgery for diagnosis and debulking allowed if frozen section shows malignant disease
• No active extra-abdominal metastatic disease and/or intrahepatic involvement secondary to metastatic carcinoma
• No borderline tumors of low malignant potential
• No abdominal disease that cannot be debulked to less than 5 mm residual disease in maximal dimension

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

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

Hepatic:

• Bilirubin less than 1.5 mg/dL
• No severe liver disease
• No cirrhosis
• No grade III or IV elevations in liver function studies

Renal:

• Creatinine no greater than upper limit of normal OR
• Creatinine clearance at least 60 mL/min

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Weight no more than 130 kg
• HIV negative
• Able to tolerate anesthesia or major surgery
• No grade III or IV peripheral neuropathy
• No regional enteritis or ulcerative colitis
• No contraindication for anesthesia or major surgery

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• Prior combination chemotherapy for malignancy allowed
• No concurrent chemotherapy except for recurrent or persistent disease

Endocrine therapy:

• Not specified

Radiotherapy:

• No concurrent radiotherapy except for recurrent or persistent disease

Surgery:

• See Disease Characteristics
• Prior surgery for malignancy allowed

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

Study chairs or principal investigators

Stephen Michael Hahn, MD,  Study Chair,  University of Pennsylvania Cancer Center   

Study ID Numbers:  CDR0000069134; UPCC-05901; NCI-4110; UPCC-IRB-702341; NCT00028782
Record last reviewed:  April 2004
Last Updated:  January 6, 2005
Record first received:  January 4, 2002
ClinicalTrials.gov Identifier:  NCT00028782
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08