Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas

November 5, 2013 updated by: Colorado Health Foundation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1A6
        • St. Michael's Hospital-Annex
  • United States
    • Colorado
      • Englewood, Colorado, United States, 80110
        • Rocky Mountain Neurological Associates
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado Health Foundation

Investigators

  • Study Chair: Fred W. Hetzel, PhD, JD, Colorado Health Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1998

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

September 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066927
  • HEALTHONE-43892
  • HEALTHONE-1A
  • HEALTHONE-CA43892
  • RPCI-DS-9802
  • NCI-V99-1525

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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