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| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-2002103 | Other Identifier | University of Miami Sylvester Comprehensive Cancer Center | |
| WIRB-20050715 | Other Identifier | Western Institutional Review Board |
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RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, precancerous cells and cancer cells are killed.
PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy with porfimer sodium works in treating patients with precancerous lesions, cancer, or other disease of the aerodigestive tract.
OBJECTIVES:
OUTLINE: Patients are stratified according to disease condition (benign vs malignant).
Patients receive porfimer sodium IV over 3-5 minutes on day 1 and laser light activation on day 3 or 4.
After completion of study treatment, patients are followed at 3 and 4 months and then periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Porfimer Sodium | Drug | Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment | Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0. | 6 months |
| Number of Participants Experiencing Adverse Events | Number of participants enrolled experiencing serious adverse events and/or other non-serious events | 6 months |
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Any of the following benign lesions:
Superficial (< 1 cm depth of invasion) squamous cell carcinoma (SCC) of the oral cavity, oropharynx, or larynx
T1-T3 disease
Meets one of the following criteria:
Condemned mucosa syndrome
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Civantos, Jr., MD | University of Miami Sylvester Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23055220 | Result | Civantos F. Photodynamic therapy for head and neck lesions in the subtropics. J Natl Compr Canc Netw. 2012 Oct 1;10 Suppl 2:S65-8. doi: 10.6004/jnccn.2012.0179. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired. Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Photodynamic Therapy | Procedure | Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired. Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Types of Lesions | The types of lesions participants had at time of enrollment | Number | participants |
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| Pathology | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment | Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0. | Posted | Number | participants | 6 months |
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| Primary | Number of Participants Experiencing Adverse Events | Number of participants enrolled experiencing serious adverse events and/or other non-serious events | Posted | Number | participants | 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired. Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home. | 24 | 45 | 12 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unfortunate Airway Disaster | Respiratory, thoracic and mediastinal disorders |
| |||
| Significant Postoperative Pain for Oral Lesions | General disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Skin Irritation | Skin and subcutaneous tissue disorders |
| |||
| Transient second-degree burn on the back of the hand | Injury, poisoning and procedural complications |
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| Inflammatory Reaction from Extravasation of Porfimer Sodium at the Intravenous Site | Injury, poisoning and procedural complications |
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| Transient Aspiration | Surgical and medical procedures |
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| Temporary edema requiring tracheotomy | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francisco Civantos MD | University of Miami Sylvester Comprehensive Cancer Center | 305-243-5276 | fcivanto@med.miami.edu |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D011230 | Precancerous Conditions |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D007972 | Leukoplakia, Oral |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009062 | Mouth Neoplasms |
| D007971 | Leukoplakia |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017323 | Dihematoporphyrin Ether |
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D017324 | Hematoporphyrin Derivative |
| D006415 | Hematoporphyrins |
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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| Other Lesions |
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| Carcinoma in situ |
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| Verrucous Carcinoma |
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