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Prospective Clinical Trials in the Use of Photodynamic Therapy (PDT) for the Treatment of Malignant Supratentorial Brain Tumors


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

Prospective Clinical Trials in the Use of Photodynamic Therapy (PDT) for the Treatment of Malignant Supratentorial Brain Tumors


OBJECTIVES:

- Determine whether the addition of photodynamic therapy to standard brain tumor care
(surgical resection, postoperative radiotherapy, and chemotherapy) will result in a
significant prolongation of time to recurrence and survival in newly diagnosed
malignant supratentorial gliomas.

- Compare the effect of high or low light dose photodynamic therapy on survival of
patients with recurrent malignant supratentorial gliomas.

OUTLINE: This is a randomized, multicenter, two part study. Patients are stratified
according to clinical center.

Newly diagnosed patients (Study 1)

- Patients are randomized to receive either high light dose photodynamic therapy (arm I)
or no photodynamic therapy (arm II):

- Arm I: Patients receive porfimer sodium (Photofrin) IV one day prior to surgery.
Craniotomy and tumor resection are performed. Upon completion of resection,
patients undergo intracavitary photoillumination with a high light dose.

- Arm II: Craniotomy and tumor resection are performed. Postoperatively, all
patients receive external beam radiotherapy 5 days per week for 5-6 weeks. After
completing radiotherapy, patients receive nitrosourea (carmustine or lomustine)
chemotherapy.

Recurrent tumor patients (Study 2)

- Patients receive Photofrin IV one day prior to surgery. Craniotomy and tumor resection
are performed.

- Arm I: Patients receive high dose light therapy during surgery.

- Arm II: Patients receive low dose light therapy during surgery. Patients receive
chemotherapy with procarbazine for 28 days beginning 2-4 weeks after surgery.
Courses repeat every 56 days in the absence of disease progression or unacceptable
toxicity.

Patients are followed on both studies at 4 weeks postsurgery, then every 3 months until
death or for 1 year after study closure.

PROJECTED ACCRUAL: A minimum of 150 patients with newly diagnosed tumor will be accrued for
this study within 4 years (Study 1). A maximum of 120 patients with recurrent disease will
be accrued within 4.5 years (Study 2)

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed or recurrent supratentorial glioblastoma or
malignant astrocytoma

- Grade 3 or 4 astrocytoma as defined by the Daumas-Duport classification

- Suitable for radical resection on the basis of imaging studies

- Patients with recurrent disease must have failed surgery and radiotherapy

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100% for newly diagnosed tumor

- Karnofsky 70-100% for recurrent tumor

Life expectancy:

- At least 3 months

Hematopoietic:

- Recurrent tumor:

- WBC at least 2,000/mm^3

- Platelet count at least 80,000/mm^3

Hepatic:

- Recurrent tumor:

- PT/PTT no greater than 1.5 times upper limit of normal (ULN)

- Bilirubin and LFTs less than 2 times ULN

- Alkaline phosphatase no greater than 3 times ULN

- GGT no greater than 3 times ULN

Renal:

- Creatinine no greater than 2 mg/dL

Other:

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No prior cranial radiotherapy for newly diagnosed tumor

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Fred W. Hetzel, PhD, JD

Investigator Role:

Study Chair

Investigator Affiliation:

Colorado Health Foundation

Authority:

United States: Federal Government

Study ID:

CDR0000066927

NCT ID:

NCT00003788

Start Date:

April 1998

Completion Date:

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Rocky Mountain Neurological AssociatesEnglewood, Colorado  80110