High Light and Low Light Dose PDT in Glioma

• Sponsor: Case Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00118222
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 1
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: porfimer sodium; Procedure: adjuvant therapy; Procedure: conventional surgery	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Mar 1, 2005
• Actual Primary Completion Date: Mar 1, 2006
• Actual Study Completion Date: Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low light dose during surgery Arm I: During surgery, patients receive low light dose photodynamic therapy.	Drug: porfimer sodium; All patients receive porfimer sodium IV.; Other Names: dihematoporphyrin ether Photofrin II Porfimer ; Procedure: adjuvant therapy; All patients receive porfimer sodium IV.; Other Names: dihematoporphyrin ether Photofrin II Porfimer ; Procedure: conventional surgery; All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.
Active Comparator: High light dose during surgery Arm II: During surgery, patients receive high light dose photodynamic therapy.	Drug: porfimer sodium; All patients receive porfimer sodium IV.; Other Names: dihematoporphyrin ether Photofrin II Porfimer ; Procedure: adjuvant therapy; All patients receive porfimer sodium IV.; Other Names: dihematoporphyrin ether Photofrin II Porfimer ; Procedure: conventional surgery; All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.

Outcome Measures

Primary Outcome Measures

1. Time to progression and survival measured [at 4-6 weeks post-operatively and then every 3-4 months thereafter]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5000

Sponsors and Collaborators

• Case Comprehensive Cancer Center
• National Cancer Institute (NCI)

Investigators

• Study Chair: Robert J. Maciunas, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00118222
• Other Study ID Numbers: CWRU4303; P30CA043703; CASE-4303; CWRU-00003937; CWRU-4303
• First Posted: Jul 11, 2005
• Last Update Posted: Jun 11, 2010
• Last Verified: Jun 1, 2010

• Keywords provided by , ,: adult mixed glioma; adult anaplastic astrocytoma; recurrent adult brain tumor; adult giant cell glioblastoma; adult gliosarcoma
• Additional relevant MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms; Dihematoporphyrin Ether; Hematoporphyrin Derivative; Ether; Trioxsalen

Study Results

No Results Posted as of Jun 11, 2010