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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

Page last updated: August 23, 2015

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