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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00028782
Other study ID # NCI-2012-02438
Secondary ID UPCC# 05901P01CA
Status Terminated
Phase N/A
First received January 4, 2002
Last updated January 15, 2013
Start date October 2001

Study information

Verified date January 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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


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).


Recruitment information / eligibility

Status Terminated
Enrollment 80
Est. completion date
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Drug:
etanidazole
Given IV
Procedure:
therapeutic conventional surgery
Undergo surgery
Other:
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States Abramson Cancer Center of The University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of hypoxia in tumor nodules Exploratory techniques will be used to describe patterns of EF5 binding as well as MVD within and among patients. At the completion of surgery No
Primary Inter- and intra-patient variability of hypoxia by EF5 binding Inter- and intra-subject variability can be estimated using summary statistics (standard deviations, or the range of data). At the completion of surgery No
Primary Levels of microvascular density by PECAM/CD31 staining Distributions of the four EF5 binding variables and MVD will be examined graphically we anticipate that certain variables may have a Poisson distribution. At the completion of surgery No
Primary Relationships among levels of hypoxia, microvascular density, and photosensitizer levels At the completion of surgery No
Primary Associations between hypoxia and photosensitizer levels in tumor nodules with clinical outcome periodically until disease recurrence Not Provided No
Secondary Toxicity of EF5 administration All observed toxicities will be graded, tabled for each stratum (IP study) and for the entire study and summarized by frequencies and percentages. Up to 45 days after EF5 infusion Yes
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