Mesothelioma Related Clinical Trials:
The Detection of Tumor Hypoxia and Vascularity in Patients Undergoing Intraperitoneal Photodynamic Therapy

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Status: Completed
Sponsors and Collaborators: University of Pennsylvania; National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00028782

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

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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.

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).

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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

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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    

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Additional Information:

Study ID Numbers:   CDR0000069134, UPCC-05901, NCI-4110, UPCC-IRB-702341
First Received:   January 4, 2002
Last Updated:   March 11, 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:
Signs and Symptoms
Antibodies
Pathologic Processes
Ascites
Neoplasm Metastasis
Mesothelioma
Adenoma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Neoplasms by Histologic Type
Mesothelioma
Neoplasms, Mesothelial
Pathological Conditions, Signs and Symptoms

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