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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]


Phase 3
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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]


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression and survival measured

Outcome Time Frame:

at 4-6 weeks post-operatively and then every 3-4 months thereafter

Safety Issue:

No

Principal Investigator

Robert J. Maciunas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU4303

NCT ID:

NCT00118222

Start Date:

March 2005

Completion Date:

March 2006

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult mixed glioma
  • adult anaplastic astrocytoma
  • recurrent adult brain tumor
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065