High Light and Low Light Dose PDT in Glioma

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]

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00118222

Enrollment

Registered

2005-07-11

Start date

2005-03-31

Completion date

2006-03-31

Last updated

2010-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Central Nervous System Tumors

Keywords

adult mixed glioma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

Brief 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.

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

DRUGporfimer sodium

All patients receive porfimer sodium IV.

PROCEDUREadjuvant therapy

All patients receive porfimer sodium IV.

PROCEDUREconventional surgery

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to progression and survival measured	at 4-6 weeks post-operatively and then every 3-4 months thereafter

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026