EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Etanidazole; Imidazole

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