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]
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
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]
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression and survival measured
Outcome Time Frame:
at 4-6 weeks post-operatively and then every 3-4 months thereafter
Safety Issue:
No
Principal Investigator
Robert J. Maciunas, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CWRU4303
NCT ID:
NCT00118222
Start Date:
March 2005
Completion Date:
March 2006
Related Keywords:
- Brain and Central Nervous System Tumors
- adult mixed glioma
- adult anaplastic astrocytoma
- recurrent adult brain tumor
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
