Clinical trial · Interventional
EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer
The Detection of Tumor Hypoxia and Vascularity in Patients Undergoing Intraperitoneal Photodynamic Therapy
NCT00028782CI-TRIAL-00008943terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
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
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Localized Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Malignant Ascites | — | UNRESOLVED | — |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
| Recurrent Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| etanidazole | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (etanidazole)
- description
- 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.
- interventionNames
- Drug: etanidazole
- Procedure: therapeutic conventional surgery
- Other: laboratory biomarker analysis
Primary outcomes (5)
- measure
- Level of hypoxia in tumor nodules
- timeFrame
- At the completion of surgery
- description
- Exploratory techniques will be used to describe patterns of EF5 binding as well as MVD within and among patients.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.