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

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ClinicalTrials.gov Identifier: NCT00003788
Recruitment Status : Unknown
Verified September 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : November 6, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: carmustine Drug: lomustine Drug: porfimer sodium Drug: procarbazine hydrochloride Procedure: neoadjuvant therapy Procedure: surgical procedure Radiation: radiation therapy Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Prospective Clinical Trials in the Use of Photodynamic Therapy (PDT) for the Treatment of Malignant Supratentorial Brain Tumors
Study Start Date : April 1998

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003788


Locations
United States, Colorado
Rocky Mountain Neurological Associates
Englewood, Colorado, United States, 80110
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Pennsylvania
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Canada, Ontario
St. Michael's Hospital-Annex
Toronto, Ontario, Canada, M5B 1A6
Sponsors and Collaborators
Colorado Health Foundation
Investigators
Study Chair: Fred W. Hetzel, PhD, JD Colorado Health Foundation
More Information
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ClinicalTrials.gov Identifier: NCT00003788     History of Changes
Other Study ID Numbers: CDR0000066927
HEALTHONE-43892
HEALTHONE-1A
HEALTHONE-CA43892
RPCI-DS-9802
NCI-V99-1525
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: September 2003

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Carmustine
Lomustine
Procarbazine
 Dihematoporphyrin Ether
Trioxsalen
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents