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High Light and Low Light Dose PDT in Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 8, 2005
First Posted Date  ICMJE July 11, 2005
Last Update Posted Date June 11, 2010
Study Start Date  ICMJE March 2005
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2010)		 Time to progression and survival measured [ Time Frame: at 4-6 weeks post-operatively and then every 3-4 months thereafter ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Light and Low Light Dose PDT in Glioma
Official Title  ICMJE 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]
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Low light dose during surgery
    Arm I: During surgery, patients receive low light dose photodynamic therapy.
    Interventions:
    • Drug: porfimer sodium
    • Procedure: adjuvant therapy
    • Procedure: conventional surgery
  • Active Comparator: High light dose during surgery
    Arm II: During surgery, patients receive high light dose photodynamic therapy.
    Interventions:
    • Drug: porfimer sodium
    • Procedure: adjuvant therapy
    • Procedure: conventional surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2010)		 1
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2006
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00118222
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Robert Maciunas, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Case Comprehensive Cancer Center
Original Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Robert J. Maciunas, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP