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

Sponsors and Collaborators:	University of Pennsylvania National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00028782

Purpose

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: This clinical 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.

Condition	Intervention
Malignant Mesothelioma Metastatic Cancer Peritoneal Cavity Cancer	Drug: EF5 Procedure: fluorescent antibody technique Procedure: immunohistochemistry staining method

MedlinePlus related topics: Cancer Mesothelioma

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	The Detection of Tumor Hypoxia and Vascularity in Patients Undergoing Intraperitoneal Photodynamic Therapy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Level of hypoxia after surgery [ Designated as safety issue: No ]
Inter- and intra-patient variability of hypoxia by EF5 binding after sugery [ Designated as safety issue: No ]
Microvascular density by PECAM/CD31 staining after surgery [ Designated as safety issue: No ]
Relationships among levels of hypoxia, microvascular density, and photosensitizer levels after surgery [ Designated as safety issue: No ]
Associations between hypoxia and photosensitizer levels in tumor nodules with clinical outcome periodically until disease recurrence [ Designated as safety issue: No ]
Toxicity at 2-3 weeks after surgery [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	October 2001
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Detailed Description:

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028782

Locations

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

Sponsors and Collaborators

University of Pennsylvania

National Cancer Institute (NCI)

Investigators

Study Chair:

Stephen Michael Hahn, MD

University of Pennsylvania

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000069134, UPCC-05901, NCI-4110, UPCC-IRB-702341
Study First Received:	January 4, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00028782
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

malignant ascites
peritoneal cavity cancer
advanced malignant mesothelioma
localized malignant mesothelioma
recurrent malignant mesothelioma

Study placed in the following topic categories:

Digestive System Neoplasms
Abdominal Neoplasms
Recurrence
Antibodies
Digestive System Diseases
Ascites
Peritoneal Diseases

Neoplasm Metastasis
Mesothelioma
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Adenoma
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Neoplasms by Site

Pathologic Processes
Neoplasms by Histologic Type
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on January 16, 2009