Photodynamic Therapy Using Porfimer Sodium in Treating Patients Who Are Undergoing Surgery for Recurrent Malignant Astrocytoma - Full Text View

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00118222

Purpose

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	Intervention
Brain and Central Nervous System Tumors	Drug: porfimer sodium Procedure: adjuvant therapy Procedure: conventional surgery

Study Type:	Interventional
Study Design:	Treatment, Randomized
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]

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

Drug Information available for: Porfimer sodium Dihematoporphyrin ether Trioxsalen

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Survival measured at 4-6 weeks post-operatively and then every 3-4 months thereafter [ Designated as safety issue: No ]
Time to progression measured at 4-6 weeks post-operatively and then every 3-4 months [ Designated as safety issue: No ]

Study Start Date:

March 2005

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118222

Locations

United States, Colorado
Rocky Mountain Neurological Alliance, P.C.
Englewood, Colorado, United States, 80110
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5000
United States, Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Canada, Ontario
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada, M5B 1W8

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Robert J. Maciunas, MD

Case Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000433267, CASE-4303, CWRU-00003937, CWRU-4303
Study First Received:	July 8, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00118222 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Adjuvants, Immunologic
Central Nervous System Neoplasms
Recurrence
Brain Neoplasms
Photosensitizing Agents
Radiation-Sensitizing Agents

Malignant Astrocytoma
Dihematoporphyrin Ether
Glioma
Hematoporphyrin Derivative
Gliosarcoma
Trioxsalen
Nervous System Neoplasms

Additional relevant MeSH terms:

Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Neoplasms
Pharmacologic Actions
Neoplasms
Photosensitizing Agents

Neoplasms by Site
Radiation-Sensitizing Agents
Dihematoporphyrin Ether
Therapeutic Uses
Trioxsalen
Dermatologic Agents
Nervous System Neoplasms

ClinicalTrials.gov processed this record on September 09, 2009