High Light and Low Light Dose PDT in Glioma
Information source: Case Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain and Central Nervous System Tumors
Intervention: porfimer sodium (Drug); adjuvant therapy (Procedure); conventional surgery (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: Case Comprehensive Cancer Center Official(s) and/or principal investigator(s): Robert J. Maciunas, MD, Study Chair, Affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Summary
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.
Clinical Details
Official title: 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 design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time to progression and survival measured
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio 44106-5000, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2005
Last updated: June 9, 2010
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