Clinical trial NCT00003788: Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas
Official title: Prospective Clinical Trials in the Use of Photodynamic Therapy (PDT) for the Treatment of Malignant Supratentorial Brain Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Brain and Central Nervous System Tumors
Keywords: recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known if the addition of photodynamic therapy to combined therapy with surgery, radiation therapy, and chemotherapy is more effective than combined therapy alone for supratentorial gliomas.

PURPOSE: Randomized phase III trial to study the effectiveness of surgery, radiation therapy, and chemotherapy with or without photodynamic therapy in treating patients who have newly diagnosed or recurrent malignant supratentorial gliomas.

Detailed description: 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)

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Rocky Mountain Neurological Associates
state: Colorado
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Toronto
country: Canada
facility: St. Michael's Hospital-Annex
state: Ontario
Study officials:
affiliation: Colorado Health Foundation
name: Fred W. Hetzel, PhD, JD
role: STUDY_CHAIR
References: