EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer
Stopped early · Not applicable
Conditions studied: Advanced Malignant Mesothelioma, Localized Malignant Mesothelioma, Malignant Ascites, Primary Peritoneal Cavity Cancer, Recurrent Malignant Mesothelioma
In brief
This phase II trial is studying how well EF5 works in detecting oxygen level and blood vessels in tumor cells of patients who are undergoing photodynamic therapy for intraperitoneal or pleural cancer. Diagnostic procedures using EF5 to detect oxygen level and blood vessels in tumor cells may help to improve the way photodynamic therapy is given
Key facts
- Study ID
- NCT00028782
- Run by
- National Cancer Institute (NCI)
- People needed
- 80
- Starts
- 2001-10-01
- Last updated by the study team
- 2013-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Abramson Cancer Center of The University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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