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High Light and Low Light Dose PDT in Glioma

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ClinicalTrials.gov Identifier: NCT00118222
Recruitment Status : Completed
First Posted : July 11, 2005
Last Update Posted : June 11, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Case Comprehensive Cancer Center

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : March 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Time to progression and survival measured [ Time Frame: at 4-6 weeks post-operatively and then every 3-4 months thereafter ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118222


Locations
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United States, Ohio
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
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Study Chair: Robert J. Maciunas, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
More Information
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Responsible Party: Robert Maciunas, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00118222    
Other Study ID Numbers: CWRU4303
P30CA043703 ( U.S. NIH Grant/Contract )
CASE-4303 ( Other Identifier: Case Comprehensive Cancer Center )
CWRU-00003937
CWRU-4303 ( Other Identifier: Case Comprehensive Cancer Center )
First Posted: July 11, 2005    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: June 2010
Keywords provided by Case Comprehensive Cancer Center:
adult mixed glioma
adult anaplastic astrocytoma
recurrent adult brain tumor
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
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Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
 Dihematoporphyrin Ether
Hematoporphyrin Derivative
Ether
Trioxsalen
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs