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Photofrin (Porfimer Sodium) - Summary

 
 



PHOTOFRIN SUMMARY

PHOTOFRIN® (porfimer sodium) for Injection

PHOTOFRIN® (porfimer sodium) for Injection is a photosensitizing agent used in the photodynamic therapy (PDT) of tumors and of high-grade dysplasia (HGD) in Barrett's esophagus (BE). Following reconstitution of the freeze-dried product with 5% Dextrose Injection (USP) or 0.9% Sodium Chloride Injection (USP), it is injected intravenously. This is followed 40-50 hours later by illumination of the tumor or HGD in BE with laser light (630 nm wavelength). PHOTOFRIN® is not a single chemical entity; it is a mixture of oligomers formed by ether and ester linkages of up to eight porphyrin units. It is a dark red to reddish brown cake or powder. Each vial of PHOTOFRIN® contains 75 mg of porfimer sodium as a sterile freeze-dried cake or powder. Hydrochloric Acid and/or Sodium Hydroxide may be added during manufacture to adjust the pH to within 7.2-7.9. There are no preservatives or other additives.

Photodynamic therapy with PHOTOFRIN® is indicated for:

  • Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy.
  • Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC).
  • Treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated.
  • Ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy.


See all Photofrin indications & dosage >>

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.

more studies >>

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).

more trials >>

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 >>


Page last updated: 2008-11-03

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