An interventional study of porfimer sodium and Photdynamic Therapy (PDT) in Head and Neck Cancer, sponsored by Roswell Park Cancer Institute. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-04.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Treatment
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using porfimer sodium may be effective against mouth or throat dysplasia and cancer of the mouth and throat.
PURPOSE: This phase I trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with recurrent mouth or throat dysplasia, recurrent in situ cancer of the mouth or throat, or stage I cancer of the mouth or throat.
OBJECTIVES:
OUTLINE: Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. Patients with incompletely treated or missed sites of disease may receive another dose of laser light on day 5 without additional porfimer sodium. Patients with multicentric disease may undergo additional PDT at least 4-6 weeks after the initial treatment.
After completion of study therapy, patients are followed for 1-2 months.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 30 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.
Drug: porfimer sodium · Drug: Photdynamic Therapy (PDT)
IV
Response
Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -\> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy. 9.23 No Response. All responses less than a Partial Response are considered as No Response. 9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia.
Time frame: 2 years
Local Toxicity
Number of patients with an adverse event
Time frame: 30 days
| Milestone | Porfimer Sodium |
|---|---|
| Started | 30 |
| Completed | 20 |
| Not completed | 10 |
| Withdrew: Disease progression | 4 |
| Withdrew: Physician decision | 4 |
| Withdrew: Other not specified | 2 |
Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -\> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy. 9.23 No Response. All responses less than a Partial Response are considered as No Response. 9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia.
| percentage of participants | Porfimer Sodium |
|---|---|
| Response | 3.5 (0 to 10) |
Number of patients with an adverse event
| participants | Porfimer Sodium |
|---|---|
| Local Toxicity | 29 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Porfimer Sodium | — | 3/30 (10%) | 29/30 (96.7%) |
| Event | Porfimer Sodium |
|---|---|
| Non-cardiac chest painGeneral disorders | 1/30 |
| PainGeneral disorders | 1/30 |
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 1/30 |
| Event | Porfimer Sodium |
|---|---|
| SunburnInjury, poisoning and procedural complications | 18/30 |
| PainGeneral disorders | 16/30 |
| OedemaGeneral disorders | 14/30 |
| ErythemaSkin and subcutaneous tissue disorders | 6/30 |
| Weight decreasedInvestigations | 5/30 |
| DysphoniaRespiratory, thoracic and mediastinal disorders | 5/30 |
| Oral painGastrointestinal disorders | 4/30 |
| ConstipationGastrointestinal disorders | 2/30 |
| OdynophagiaGastrointestinal disorders | 2/30 |
| Oedema mouthGastrointestinal disorders | 2/30 |
All treated and eligible patients
| Age, Continuous(years) | Porfimer Sodium |
|---|---|
| Mean | 60.8 ± 10.1 |
| Age, Categorical(Participants) | Porfimer Sodium |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 11 |
| Sex: Female, Male(Participants) | Porfimer Sodium |
|---|---|
| Female | 8 |
| Male | 22 |
This study is terminated, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Roswell Park Cancer Institute