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High Light and Low Light Dose PDT in Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
porfimer sodium
adjuvant therapy
conventional surgery
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult mixed glioma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low light dose during surgery

High light dose during surgery

Arm Description

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

Arm II: During surgery, patients receive high light dose photodynamic therapy.

Outcomes

Primary Outcome Measures

Time to progression and survival measured

Secondary Outcome Measures

Full Information

First Posted
July 8, 2005
Last Updated
June 9, 2010
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00118222
Brief Title
High Light and Low Light Dose PDT in Glioma
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 Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult mixed glioma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low light dose during surgery
Arm Type
Active Comparator
Arm Description
Arm I: During surgery, patients receive low light dose photodynamic therapy.
Arm Title
High light dose during surgery
Arm Type
Active Comparator
Arm Description
Arm II: During surgery, patients receive high light dose photodynamic therapy.
Intervention Type
Drug
Intervention Name(s)
porfimer sodium
Other Intervention Name(s)
dihematoporphyrin ether, Photofrin II, Porfimer
Intervention Description
All patients receive porfimer sodium IV.
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Other Intervention Name(s)
dihematoporphyrin ether, Photofrin II, Porfimer
Intervention Description
All patients receive porfimer sodium IV.
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.
Primary Outcome Measure Information:
Title
Time to progression and survival measured
Time Frame
at 4-6 weeks post-operatively and then every 3-4 months thereafter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J. Maciunas, MD
Organizational Affiliation
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5000
Country
United States

12. IPD Sharing Statement

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High Light and Low Light Dose PDT in Glioma

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