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Photodynamic Therapy (PDT) for Poor Prognosis Recurrent/Refractory Malignant Brain Tumors - A Phase I Study

Phase 1
6 Months
18 Years
Open (Enrolling)
Brain Tumor, Recurrent

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Trial Information

Photodynamic Therapy (PDT) for Poor Prognosis Recurrent/Refractory Malignant Brain Tumors - A Phase I Study

Inclusion Criteria:

Subjects with malignant brain tumors will be selected for photodynamic therapy if they
meet all of the following criteria.

1. Age: 6 months-18 years.

2. Location of tumor: supra- or infratentorial brain (localized, non-disseminated) with
negative CSF.

3. Tumor type: primary, or solitary metastasis, recurrent (or progressive), and

4. MRI/CT scan characteristics:

- measurable tumor mass

- single or multiple masses accessible to light administration.

5. Subjects must have been failed by standard therapy including radiation therapy.

6. Informed consent of subject and/or the patient's legally acceptable representative.

7. Predicted life expectancy more than or equal to 8 weeks.

8. May transfuse platelets. ANC (absolute neutrophil count) more than 1,000/cmm. Coags
(PT, PTT) normal.

9. Adequate renal function defined as:

- Creatinine or radioisotope GFR more than or equal to 70 ml/min/1.73m2 or

- A serum creatinine based on age/gender within normal limits.

10. Adequate liver function defined as:

- Bilirubin (sum of conjugated + unconjugated) less than or equal to 1.5 times the
upper limit of normal (ULN) for age.

- SGPT (ALT) less than or equal to 110 U/L. For the purpose of this study, the ULN
for SGPT is 45 U/L.

- Serum albumin more than or equal to 2 g/dL.

Exclusion Criteria:

Subjects will be excluded from participation in the study on the basis of the following:

1. Life expectancy of less than 8 weeks.

2. Pregnancy.

3. Inability to consent.

4. Previous brachytherapy.

5. Previous chemotherapy within 4 weeks of enrollment.

6. Other concurrent tumor therapy.

7. Subjects with porphyria.

8. Subjects taking tetracycline, sulfonamides, phenothiazines, sulfonylureas, thiazides,
griseofulvin, fluoroquinolones, or any other potentially photosensitizing drugs.

9. Previous radiation therapy within 8 weeks of enrollment.

10. The presence of adverse events of neurologic function, photosensitivity, or
photophobia grade 4 or higher (CTCAE Version 4.02).

11. Karnofsky functional status or Lansky play scale score of less than 50.

12. Allergy to eggs, soybean oil, or safflower oil.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerable dose (MTD) of Photofrin® in pediatric subjects

Outcome Description:

MTD is defined as the Photofrin® dose that precedes the dose level used with a subgroup of subjects that exhibits a greater than 33% DLT occurrence. DLT is defined as any of the following events with reasonable possibility to be attributable to the experimental intervention: Neurotoxicity: defined as a decline in neurological function manifest within 1 week of PDT and persistent to 4 weeks post-PDT. Adverse events of neurologic function of grade 4, or a level change from grade 1 to grade 3, within this period will constitute neurotoxicity for this study. The CTCAE V4.02 will be used. Photosensitivity: defined as a photosensitivity adverse event (CTCAE category dermatology/skin) of grade 4 occurring within the same period. Ocular sensitivity: Photofrin®-induced ocular sensitivity is defined as a photophobia adverse event (CTCAE category ocular/visual) of grade 4 within the same period. Any other toxicity of CTCAE grade 4 or higher within the same period.

Outcome Time Frame:

One to four weeks from PDT

Safety Issue:


Principal Investigator

Harry T Whelan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin


United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

April 2021

Related Keywords:

  • Brain Tumor, Recurrent
  • Brain Tumor
  • Photodynamic Therapy
  • Photochemotherapy
  • Brain Neoplasms



Children's Hospital of Wisconsin Milwaukee, Wisconsin  53201