NEWS HIGHLIGHTS
Published Studies Related to Photofrin (Porfimer)
ALA and Photofrin(R) Fluorescence-guided resection and repetitive PDT in glioblastoma multiforme: a single centre Phase III randomised controlled trial. [2008.10]
Glioblastoma multiforme (GBM) carries dismal prognosis and cannot be eradicated surgically because of its wide brain invasion. The objective of this prospective randomised controlled trial was to evaluate ALA and Photofrin(R) fluorescence-guided resection (FGR) and repetitive photodynamic therapy (PDT) in GBM...
ALA and Photofrin(R) Fluorescence-guided resection and repetitive PDT in glioblastoma multiforme: a single centre Phase III randomised controlled trial. [2007.10.10]
Glioblastoma multiforme (GBM) carries dismal prognosis and cannot be eradicated surgically because of its wide brain invasion. The objective of this prospective randomised controlled trial was to evaluate ALA and Photofrin(R) fluorescence-guided resection (FGR) and repetitive photodynamic therapy (PDT) in GBM...
Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett's esophagus: international, partially blinded, randomized phase III trial. [2005.10]
BACKGROUND: Barrett's esophagus (BE) may lead to high-grade dysplasia (HGD) and adenocarcinoma. The objective was to examine the impact of treating patients with BE and with HGD by using porfimer sodium (POR) and photodynamic therapy (PDT) for ablating HGD and reducing the incidence of esophageal adenocarcinoma... CONCLUSIONS: PORPDT in conjunction with omeprazole is an effective therapy for ablating HGD in patients with BE and in reducing the incidence of esophageal adenocarcinoma.
A multispectral fluorescence imaging system: design and initial clinical tests in intra-operative Photofrin-photodynamic therapy of brain tumors. [2003]
BACKGROUND AND OBJECTIVES: Intra-operative identification of tumor by fluorescence may improve surgical resection or photodynamic therapy (PDT). A novel instrument was designed, constructed, and tested for this purpose... CONCLUSIONS: The system performed to specification under realistic operating conditions and could reveal unresected residual tumor tissue. It may be used for either PDT dosimetry/monitoring and/or for surgical guidance. Copyright 2003 Wiley-Liss, Inc.
Photodynamic therapy with porfimer sodium versus thermal ablation therapy with Nd:YAG laser for palliation of esophageal cancer: a multicenter randomized trial. [1995.12]
BACKGROUND: Photodynamic therapy (PDT) is a different type of laser treatment from Nd:YAG thermal ablation for palliation of dysphagia from esophageal cancer... CONCLUSIONS: Photodynamic therapy with porfimer sodium has overall equal efficacy to Nd:YAG laser thermal ablation for palliation of dysphagia in esophageal cancer, and equal or better objective tumor response rate. Temporary photosensitivity is a limitation, but PDT is carried out with greater ease and is associated with fewer acute perforations than Nd:YAG laser therapy.
Clinical Trials Related to Photofrin (Porfimer)
Ultrasound-Guided Photodynamic Therapy With Photofrin & Gemcitabine for Patients With Locally Advanced Pancreatic Cancer [Not yet recruiting]
This phase I trial studies the side effects and best dose of ultrasound-guided photodynamic
therapy with porfimer sodium when given together with gemcitabine hydrochloride in treating
patients with locally advanced pancreatic cancer. Photodynamic therapy uses a drug, porfimer
sodium, that becomes active when it is exposed to a certain kind of light. When the drug is
active, cancer cells are killed. Drugs used in chemotherapy, such as gemcitabine
hydrochloride, work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. Giving photodynamic therapy together with
gemcitabine hydrochloride may be effect in patients with pancreatic cancer.
Photodynamic Therapy (PDT) for Brain Tumors [Not yet recruiting]
The goal of this proposal is to evaluate a new Photodynamic Therapy (PDT) modification which
could revolutionize the treatment of brain tumors in children and adults. There are
currently few cases published involving the use of PDT in infratentorial (in the posterior
fossa) brain tumors in general and specifically those occurring in children. The
investigators propose to test a technique, for the first time in the U. S., that demonstrated
in Australian adult glioblastoma patients dramatic long-term, survival rates of 57%
(anaplastic astrocytoma) and 37% (glioblastoma multiforme). These results are unprecedented
in any other treatment protocol.
Photodynamic therapy (PDT) is a paradigm shift in the treatment of tumors from the
traditional resection and systemic chemotherapy methods. The principle behind photodynamic
therapy is light-mediated activation of a photosensitizer that is selectively accumulated in
the target tissue, causing tumor cell destruction through singlet oxygen production.
Therefore, the photosensitizer is considered to be the first critical element in PDT
procedures, and the activation procedure is the second step. The methodology used in this
proposal utilizes more intensive laser light and larger Photofrin photosensitizer doses than
prior PDT protocols in the U. S. for brain tumor patients. The PDT will consist of
photoillumination at 630 nm beginning at the center of the tumor resection cavity, and
delivering a total energy of 240 J cm−2. The investigators feel that the light should
penetrate far enough into the tissue to reach migrating tumor cells, and destroy these cells
without harming the healthy cells in which they are dispersed.
The investigators will be testing the hypothesis that pediatric subjects with
progressive/recurrent malignant brain tumors undergoing PDT with increased doses of
Photofrin® and light energy than were used in our previous clinical study will show better
progression free survival (PFS) and overall survival (OS) outcomes. PDT will also be
effective against infratentorial tumors. The specific aims include determining the maximum
tolerable dose (MTD) of Photofrin in children and looking for preliminary effectiveness
trends.
Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer [Recruiting]
This protocol is evaluating efficacy and toxicity of three sequential whole bladder
photodynamic treatment with Photofrin and red laser light (630 nm) in the management of
superficial bladder cancer (non-muscle invasive) in those patients who have failed or are
not candidates for conventional intravesical therapy.
Photodynamic Therapy Using Porfimer Sodium in Treating Patients Who Are Undergoing Surgery for Recurrent Malignant Astrocytoma [Active, not recruiting]
RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active
when it is exposed to a certain kind of light. When the drug is active, tumor cells are
killed. Giving photodynamic therapy after surgery may kill any remaining tumor cells.
PURPOSE: This randomized clinical trial is studying two different light doses of photodynamic
therapy using porfimer sodium to compare how well they work in treating patients who are
undergoing surgery for recurrent malignant astrocytoma.
Efficacy and Safety of a Sunscreen Against Porfimer Sodium-induced Phototoxicity to Visible Light [Not yet recruiting]
Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a
non heated laser. The activation of the drug is done by illuminating abnormal areas using a
fiber optic device. The fiber optic device is a very fine fiber (like fishing line) that
permits transmission of light. By itself, porfimer sodium is inactive. However it becomes
active when it is put in the presence of a light source such as sunlight, very intense
indoor light, or laser. Therefore, the main risk with this therapy is that the skin will be
more sensitive to light, and this sensibility can last up to 90 days. The skin reaction is
similar to sunburn and is called phototoxicity.
To date, no product on the market has shown protection against visible light, and therefore,
no product has been demonstrated to protect against the skin phototoxicity to visible light.
A sunscreen sold under the brand name Solar Protection Formula® SPF 60 in the United States
contains ingredients that provide maximum ultraviolet (UV) protection, as well as a
formulation that could provide visible light protection. The product could potentially
prevent the skin phototoxicity due to visible light, the most frequently reported side
effect in patients receiving PDT with porfimer sodium. Therefore, this study is designed to
assess the efficacy of topical application of Solar Protection Formula® SPF 60 as skin
protector against visible light-induced skin redness and swelling following injection of
porfimer sodium. It will involve 17 human subjects in the United States for whom PDT with
porfimer sodium is planned for the treatment of high-grade dysplasia in Barrett's esophagus
[(pre-cancerous change in the food pipe tissue), HGD in BE], lung cancer, or cancer of the
esophagus (food pipe).
Reports of Suspected Photofrin (Porfimer) Side Effects
OFF Label USE (48),
Cholangitis (27),
Liver Abscess (7),
Oesophageal Fistula (4),
Cholecystitis (3),
Aorto-Oesophageal Fistula (2),
Haemobilia (2),
Oesophageal Ulcer (2),
Infectious Peritonitis (2),
Bacteraemia (2), more >>
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