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Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors

Study Purpose

RATIONALE: Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells and may be an effective treatment for refractory brain tumors. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using porfimer sodium in treating patients with refractory brain tumors, including astrocytoma, ependymoma, and medulloblastoma.

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 3 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Diagnosis of supratentorial or infratentorial brain tumor.
  • - Localized, non-disseminated.
  • - Primary tumor or solitary metastasis.
  • - Recurrent or progressive.
  • - Unresectable.
  • - Negative CSF.
  • - Must have failed standard therapy including radiotherapy.
  • - Measurable disease as evidenced by CT scan or MRI.
  • - Single or multiple masses accessible to light administration.
PATIENT CHARACTERISTICS: Age:
  • - 3 to 70.
Performance status:
  • - Not specified.
Life expectancy:
  • - At least 2 months.
Hematopoietic:
  • - Absolute neutrophil count at least 1,000/mm3.
  • - May transfuse platelets.
Hepatic:
  • - PT and PTT normal.
Renal:
  • - Not specified.
Other:
  • - Not pregnant.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - Not specified.
Chemotherapy:
  • - At least 6 weeks since prior chemotherapy.
Endocrine therapy:
  • - Not specified.
Radiotherapy:
  • - See Disease Characteristics.
  • - No prior brachytherapy.
Surgery:
  • - See Disease Characteristics.
Other: - No other concurrent antitumor therapy

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.

 NCT00002647
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 1
Lead Sponsor

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

 Medical College of Wisconsin
Principal Investigator

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

 Harry T. Whelan, MD
Principal Investigator Affiliation Medical College of Wisconsin
Agency Class

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

 Other
Overall Status Unknown status
Countries United States
Conditions

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

 Brain and Central Nervous System Tumors, Metastatic Cancer
Additional Details

OBJECTIVES:

  • - Determine the maximum tolerated dose of benzoporphyrin monoacid ring A in patients with refractory brain tumors undergoing cavitary photoillumination photodynamic therapy.
  • - Determine the effect of this regimen on neurotoxicity, clinical state, imaging changes, and survival of these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to tumor location (posterior fossa tumors vs.#46;all other brain tumors). Patients receive benzoporphyrin monoacid ring A (BPD-MA) IV preoperatively. Approximately 3 hours after BPD-MA administration, patients undergo craniotomy with photoillumination of the tumor. Patients with tumors greater than 2 cm in diameter also undergo gross tumor resection. Cohorts of 3-6 patients receive escalating doses of BPD-MA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Three additional patients are treated at the MTD. Patients are followed at 4 and 6 weeks, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A minimum of 24 patients will be accrued for this study within 3 years.

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.

Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226

Site Contact

Clinical Trials Office - Medical College of Wisconsin Cancer C

414-805-4380

Milwaukee, Wisconsin

Status

Recruiting

Address

Midwest Children's Cancer Center at Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

Bruce A. Kaufman, MD

414-266-2000

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