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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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00003788
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Colorado Health Foundation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Fred W. Hetzel, PhD, JD
Principal Investigator Affiliation Colorado Health Foundation
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rocky Mountain Neurological Associates, Englewood, Colorado

Status

Address

Rocky Mountain Neurological Associates

Englewood, Colorado, 80110

Roswell Park Cancer Institute, Buffalo, New York

Status

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001

Western Pennsylvania Hospital, Pittsburgh, Pennsylvania

Status

Address

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224

International Sites

St. Michael's Hospital-Annex, Toronto, Ontario, Canada

Status

Address

St. Michael's Hospital-Annex

Toronto, Ontario, M5B 1A6

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