High Light and Low Light Dose PDT in Glioma

Overview

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.

Full Title of Study: “A Randomized Prospective Two Arm Clinical Trial of High Light Dose And Low Light Dose PDT in the Treatment of Recurrent Malignant Supratentorial Gliomas Using Porfimer Sodium [Photofrin]“

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2006

Detailed Description

OBJECTIVES:

- Compare survival of patients undergoing surgical resection for recurrent high-grade malignant supratentorial astrocytoma treated with intraoperative high vs low light dose photodynamic therapy using porfimer sodium.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.

- Arm I: During surgery, patients receive low light dose photodynamic therapy.

- Arm II: During surgery, patients receive high light dose photodynamic therapy. After completion of study treatment, patients are followed at 1 day, 6 weeks, and 3 months and then every 3 months for up to 2 years.

PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study within 4-5 years.

Interventions

  • Drug: porfimer sodium
    • All patients receive porfimer sodium IV.
  • Procedure: adjuvant therapy
    • All patients receive porfimer sodium IV.
  • Procedure: conventional surgery
    • All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.

Arms, Groups and Cohorts

  • Active Comparator: Low light dose during surgery
    • Arm I: During surgery, patients receive low light dose photodynamic therapy.
  • Active Comparator: High light dose during surgery
    • Arm II: During surgery, patients receive high light dose photodynamic therapy.

Clinical Trial Outcome Measures

Primary Measures

  • Time to progression and survival measured
    • Time Frame: at 4-6 weeks post-operatively and then every 3-4 months thereafter

Participating in This Clinical Trial

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant supratentorial astrocytoma, glioblastoma, or mixed oligo-astrocytoma
  • Grade 3 or 4 tumor, defined as presence of ≥ 2 of the following features:
  • Nuclear atypia
  • Mitosis
  • Endothelial proliferation
  • Necrosis
  • Recurrent disease
  • Failed prior surgery and radiotherapy
  • Tumor suitable for radical resection by imaging studies

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 3 months

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Willing to avoid direct sun-light exposure for 6 weeks after photodynamic therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Case Comprehensive Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Robert Maciunas, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  • Overall Official(s)
    • Robert J. Maciunas, MD, Study Chair, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

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