High Light and Low Light Dose PDT in Glioma

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Completed; Phase 3

Conditions: Brain and Central Nervous System Tumors

Treatments: Procedure: conventional surgery; Drug: porfimer sodium; Procedure: adjuvant therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00118222

CWRU-4303 (Other Identifier)

CASE-4303 (Other Identifier)

CWRU4303

P30CA043703 (U.S. NIH Grant/Contract)

CWRU-00003937

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Low light dose during surgery

Active Comparator group

Description:

Arm I: During surgery, patients receive low light dose photodynamic therapy.

Treatment:

Procedure: conventional surgery

Procedure: adjuvant therapy

Drug: porfimer sodium

High light dose during surgery

Active Comparator group

Description:

Arm II: During surgery, patients receive high light dose photodynamic therapy.

Treatment:

Procedure: conventional surgery

Procedure: adjuvant therapy

Drug: porfimer sodium