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

National Cancer Institute (NCI)

Status

Terminated

Conditions

Primary Peritoneal Cavity Cancer

Advanced Malignant Mesothelioma

Recurrent Malignant Mesothelioma

Localized Malignant Mesothelioma

Malignant Ascites

Treatments

Drug: etanidazole

Other: laboratory biomarker analysis

Procedure: therapeutic conventional surgery

Study type

Interventional

Funder types

NIH

Identifiers

NCT00028782

CDR0000069134 (Registry Identifier)

NCI-2012-02438

P01CA087971 (U.S. NIH Grant/Contract)

UPCC# 05901

Details and patient eligibility

About

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

Full description

OBJECTIVES:

I. Determine the level of hypoxia through etanidazole derivative EF5 binding in patients with intraperitoneal or pleural malignancies treated with photodynamic therapy.

II. Determine the microvascular density in this patient population. III. Determine the relationships between levels of hypoxia, measures of microvascular density, and photosensitizer levels in this patient population.

IV. Correlate hypoxia and photosensitizer levels with clinical outcome in this patient population.

V. 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).

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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