High Light and Low Light Dose PDT in Glioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00118222
First received: July 8, 2005
Last updated: June 9, 2010
Last verified: June 2010
  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 Phase
Brain and Central Nervous System Tumors
Drug: porfimer sodium
Procedure: adjuvant therapy
Procedure: conventional surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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]

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Time to progression and survival measured [ Time Frame: at 4-6 weeks post-operatively and then every 3-4 months thereafter ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: March 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Investigators
Study Chair: Robert J. Maciunas, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Robert Maciunas, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00118222     History of Changes
Other Study ID Numbers: CWRU4303, P30CA043703, CASE-4303, CWRU-00003937, CWRU-4303
Study First Received: July 8, 2005
Last Updated: June 9, 2010
Health Authority: United States: Federal Government

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:
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
Trioxsalen
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014