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High Light and Low Light Dose PDT in Glioma

Study Purpose

RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Giving photodynamic therapy after surgery may kill any remaining tumor cells. PURPOSE: This randomized clinical trial is studying two different light doses of photodynamic therapy using porfimer sodium to compare how well they work in treating patients who are undergoing surgery for recurrent malignant astrocytoma.

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 malignant supratentorial astrocytoma, glioblastoma, or mixed oligo-astrocytoma.
  • - Grade 3 or 4 tumor, defined as presence of ≥ 2 of the following features: - Nuclear atypia.
  • - Mitosis.
  • - Endothelial proliferation.
  • - Necrosis.
  • - Recurrent disease.
  • - Failed prior surgery and radiotherapy.
  • - Tumor suitable for radical resection by imaging studies.
PATIENT CHARACTERISTICS: Age.
  • - 18 and over.
Performance status.
  • - Karnofsky 60-100% Life expectancy.
  • - At least 3 months.
Hematopoietic.
  • - Not specified.
Hepatic.
  • - Not specified.
Renal.
  • - Not specified.
Other.
  • - Not pregnant or nursing.
  • - Fertile patients must use effective contraception.
  • - Willing to avoid direct sun-light exposure for 6 weeks after photodynamic therapy.
PRIOR CONCURRENT THERAPY: Biologic therapy.
  • - Not specified.
Chemotherapy.
  • - Not specified.
Endocrine therapy.
  • - Not specified.
Radiotherapy.
  • - See Disease Characteristics.
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.

 NCT00118222
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.

 Case Comprehensive Cancer Center
Principal Investigator

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

 Robert J. Maciunas, MD
Principal Investigator Affiliation Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Agency Class

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

 Other, NIH
Overall Status Completed
Countries United States
Conditions

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

 Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES:

  • - Compare survival of patients undergoing surgical resection for recurrent high-grade malignant supratentorial astrocytoma treated with intraoperative high vs.#46;low light dose photodynamic therapy using porfimer sodium.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. All patients receive porfimer sodium
  • IV. One day later, patients undergo craniotomy and tumor resection.
  • - Arm I: During surgery, patients receive low light dose photodynamic therapy.
  • - Arm II: During surgery, patients receive high light dose photodynamic therapy.
After completion of study treatment, patients are followed at 1 day, 6 weeks, and 3 months and then every 3 months for up to 2 years. PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study within 4-5 years.

Arms & Interventions

Arms

Active Comparator: Low light dose during surgery

Arm I: During surgery, patients receive low light dose photodynamic therapy.

Active Comparator: High light dose during surgery

Arm II: During surgery, patients receive high light dose photodynamic therapy.

Interventions

Drug: - porfimer sodium

All patients receive porfimer sodium IV.

Procedure: - adjuvant therapy

All patients receive porfimer sodium IV.

Procedure: - conventional surgery

All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.

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.

Cleveland, Ohio

Status

Address

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5000

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