Photodynamic Therapy (PDT) For Recurrent High Grade Gliomas

NCT01966809 | Terminated Phase 2 Results DMC

• 1 other identifier: PRO00023580
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Tumor, Recurrent

Keywords

Brain Tumor; Photodynamic Therapy; Photochemotherapy; Astrocytoma; Pilocytic Astrocytoma; Low grade Astrocytoma; Anaplastic Astrocytoma; Glioblastoma; GBM; Chordoma; Germinoma; Germ Cell Tumor; Non-germinoma; CNS Lymphoma; Craniopharyngioma; Mixed Glioma; Optic Nerve Glioma; Meningioma; Oligodendroglioma; Pituitary Tumors; Desmoplastic Neuroepithelial Tumor; DNET; glioblastoma multiforme; glioma; glioblastoma survivors; what is glioblastoma; gbm cancer; oligoastrocytoma; gbm tumor; anaplastic oligodendroglioma; High-Grade Glioma; high grade glioma; glioblastomas; glioblastoma cancer; anaplastic oligoastrocytoma; astrocytoma glioma; glioblastoma clinical trials; photodynamic therapy for cancer; glioblastoma multiforme clinical trials; astrocytoma glioblastoma; gbm grade 4; clinical trials for glioblastoma; photodynamic therapy cancer; clinical trials glioblastoma; glioblastoma clinical trials 2015; glioblastoma clinical trials 2014 not open in 2014; glioblastoma trials; gbm clinical trials; glioblastoma immunotherapy; malignant gliomas; anaplastic astrocytomas; immunotherapy for glioblastoma; immunotherapy glioblastoma; High Grade Glioblastoma Multiforme; clinical trial glioblastoma; glioblastoma clinical trial; glioblastoma trial; brain tumors; recurrent brain tumors; glioma grade 3; grade 3 brain tumor; grade 4 brain tumor

Outcome Measures

Primary Outcomes (1)

• Six Month Relapse-free Survival (RFS).

  Relapse free survival is the proportion of subjects who have gone six months since PDT without the disease getting worse.

  Six months from PDT

Secondary Outcomes (3)

• Remission Rate.

  Three years from PDT

• Progression-free Survival and Overall Survival.

  Three years from PDT

• Tumor Response.

  Six months from PDT

Study Arms (1)

Photofrin photodynamic therapy.

EXPERIMENTAL

Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2.

Drug: Photofrin photodynamic therapy.

Interventions

Photofrin photodynamic therapy. DRUG

The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula: Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence. After PDT, the Intralipid solution will be removed and the wound will be closed. The subject will be sent to the intensive care area for recovery.

Photofrin photodynamic therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Greater than or equal to 18 years of age.
• 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.
• Disease Status: Patients must have potentially resectable disease.
• 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.
• 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.
• Predictable Life Expectancy: \> 8weeks
• 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.
• 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.
• Central Nervous System Function: Patients with seizure disorder may be enrolled if receiving non-enzyme inducing anticonvulsants and well controlled.
• Informed Consent: All patients or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
• Archival tumor tissue slides from initial diagnosis should be reviewed by Froedtert Health-MCW neuropathologist prior to study enrollment whenever possible.

You may not qualify if:

• Disseminated disease
• 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.
• Other concurrent tumor therapy
• Subjects with porphyria
• Subjects taking potentially photosensitizing drugs (Appendix 3)
• The presence of adverse events of neurologic function, photosensitivity, or photophobia Grade 4 or higher (CTCAE Version 4.02).47
• Allergy to eggs, soybean oil, or safflower oil (due to potential allergy against intralipids)
• 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.

Sponsors & Collaborators

• Harry T Whelan, MD: lead
• Pinnacle Biologics Inc.: collaborator

Study Sites (1)

Medical College of Wisconsin/ Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Astrocytoma; Glioblastoma; Chordoma; Germinoma; Neoplasms, Germ Cell and Embryonal; Craniopharyngioma; Glioma; Optic Nerve Glioma; Meningioma; Oligodendroglioma; Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Endocrine Gland Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Limitations and Caveats

Early termination with only one participant enrolled.

Results Point of Contact

• Title: Dr. Harry T. Whelan
• Organization: Medical College of Wisconsin

hwhelan@mcw.edu

414-266-7516

Study Officials

• Harry T Whelan, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Bleser Professor of Neurology

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 22, 2013
• Study Start: June 1, 2015
• Primary Completion: December 19, 2017
• Study Completion: December 19, 2017
• Last Updated: August 20, 2019
• Results First Posted: August 8, 2019

Record last verified: 2019-08

Locations

US (1)