Photodynamic Therapy (PDT) For Recurrent High Grade Gliomas

About this trial

Last updated 7 years ago

Study ID

PRO00023580

Status

Terminated

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Ended 8 years ago

What is this trial about?

This study will be aimed at investigating the effectiveness of a treatment for brain tumors called Photodynamic Therapy, or PDT. Briefly, a subject will receive a light-sensitive drug, called Photofrin®, the day before a tumor removal surgery. The next day, after the tumor is removed, red light from a laser will be shone into the tumor cavity through a light-diffusing sphere. This light will activate the photosensitizer, and possibly kill any tumor cells that may be left. We plan to measure how long the subject may go without a new tumor regrowth, and overall how long subjects survive. We will compare these results to typical results to see if we are seeing any improvements. Objective: To define the antitumor activity of Photofrin® and laser light activation within the confines of a Phase II study.

What are the participation requirements?

Inclusion Criteria

1. Age: Greater than or equal to 18 years of age.

2. Disease: Patients with relapsed or refractory high grade glioma are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse. Tumors must be supratentorial in location.

3. Disease Status: Patients must have potentially resectable disease.

4. Therapeutic Options: Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.

5. Performance Level: Karnofsky 50% or greater. Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.

6. Predictable Life Expectancy: > 8weeks

7. Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy. At least three weeks from previous chemotherapy and 4 weeks from prior radiation therapy.

8. Organ Function: a. Adequate bone marrow function i. Absolute neutrophil count ≥ 1,000 ii. Platelet count ≥ 100,000 (may transfuse to meet requirement) b. Adequate renal function i. Creatinine clearance or radioisotope GFR ≥ 60 mL/min/1.73 m2 or ii. A serum creatinine within normal range based on age/gender. c. Adequate liver function i. Bilirubin (direct) ≤ 3X upper limit of normal (ULN) for age ii. SGPT (ALT) ≤ 10X ULN. For the purpose of this study, the ULN for SGPT is 45 U/L. iii. Serum albumin ≥ 2 g/dL. d. Adequate coagulation i. PT and INR ≤ 2X ULN for age.

9. Central Nervous System Function: Patients with seizure disorder may be enrolled if receiving non-enzyme inducing anticonvulsants and well controlled.

10. Informed Consent: All patients or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

11. Archival tumor tissue slides from initial diagnosis should be reviewed by Froedtert Health-MCW neuropathologist prior to study enrollment whenever possible.

Exclusion Criteria

1. Disseminated disease

2. Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study, as risks of fetal and teratogenic adverse effects of Photofrin® are not known.

3. Other concurrent tumor therapy

4. Subjects with porphyria

5. Subjects taking potentially photosensitizing drugs (Appendix 3)

6. The presence of adverse events of neurologic function, photosensitivity, or photophobia Grade 4 or higher (CTCAE Version 4.02).47

7. Allergy to eggs, soybean oil, or safflower oil (due to potential allergy against intralipids)

8. Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.