EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer
Advanced Malignant Mesothelioma, Localized Malignant Mesothelioma, Malignant Ascites
About this trial
This is an interventional diagnostic trial for Advanced Malignant Mesothelioma
Eligibility Criteria
Inclusion Criteria: 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 Performance status - ECOG 0-2 WBC at least 2,000/mm^3 Platelet count greater than 100,000/mm^3 Bilirubin less than 1.5 mg/dL No severe liver disease No cirrhosis No grade III or IV elevations in liver function studies Creatinine no greater than upper limit of normal Creatinine clearance at least 60 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after completion of study treatment 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 combination chemotherapy for malignancy allowed No concurrent chemotherapy except for recurrent or persistent disease No concurrent radiotherapy except for recurrent or persistent disease Prior surgery for malignancy allowed
Sites / Locations
- Abramson Cancer Center of The University of Pennsylvania
Arms of the Study
Arm 1
Experimental
Diagnostic (etanidazole)
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.