NCT00002647

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1994

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 20, 2013

Status Verified

June 1, 2009

First QC Date

November 1, 1999

Last Update Submit

September 19, 2013

Conditions

Brain and Central Nervous System TumorsMetastatic Cancer

Keywords

recurrent adult brain tumortumors metastatic to brainrecurrent childhood brain stem gliomarecurrent childhood anaplastic astrocytomarecurrent childhood anaplastic oligoastrocytomarecurrent childhood anaplastic oligodendrogliomarecurrent childhood cerebellar astrocytomarecurrent childhood cerebral astrocytomarecurrent childhood diffuse astrocytomarecurrent childhood fibrillary astrocytomarecurrent childhood gemistocytic astrocytomarecurrent childhood giant cell glioblastomarecurrent childhood glioblastomarecurrent childhood gliomatosis cerebrirecurrent childhood gliosarcomarecurrent childhood oligodendrogliomarecurrent childhood pilocytic astrocytomarecurrent childhood pilomyxoid astrocytomarecurrent childhood pleomorphic xanthoastrocytomarecurrent childhood protoplasmic astrocytomarecurrent childhood subependymal giant cell astrocytomarecurrent childhood visual pathway and hypothalamic gliomarecurrent childhood visual pathway gliomarecurrent childhood pineoblastomarecurrent childhood supratentorial primitive neuroectodermal tumorrecurrent childhood medulloblastomarecurrent childhood ependymomarecurrent childhood brain tumoradult anaplastic astrocytomaadult anaplastic ependymomaadult anaplastic meningiomaadult anaplastic oligodendrogliomaadult brain stem gliomaadult central nervous system germ cell tumoradult choroid plexus tumoradult craniopharyngiomaadult diffuse astrocytomaadult ependymoblastomaadult ependymomaadult giant cell glioblastomaadult glioblastomaadult gliosarcomaadult medulloblastomameningeal melanocytomaadult meningeal hemangiopericytomaadult oligodendrogliomaadult papillary meningiomaadult pilocytic astrocytomaadult pineal gland astrocytomaadult pineoblastomaadult pineocytomaadult subependymal giant cell astrocytomaadult subependymomaadult supratentorial primitive neuroectodermal tumor (PNET)childhood grade I meningiomachildhood grade II meningiomachildhood grade III meningiomaadult grade III meningiomachildhood central nervous system germ cell tumorchildhood choroid plexus tumorchildhood craniopharyngiomachildhood infratentorial ependymomachildhood supratentorial ependymomachildhood low-grade cerebral astrocytomachildhood high-grade cerebral astrocytoma

Interventions

verteporfinDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

RECRUITING

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

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (1)

  • Schmidt MH, Bajic DM, Reichert KW 2nd, Martin TS, Meyer GA, Whelan HT. Light-emitting diodes as a light source for intraoperative photodynamic therapy. Neurosurgery. 1996 Mar;38(3):552-6; discussion 556-7. doi: 10.1097/00006123-199603000-00025.

    PMID: 8837808BACKGROUND

MeSH Terms

Conditions

Central Nervous System NeoplasmsNeoplasm MetastasisBrain NeoplasmsAstrocytomaOligodendrogliomaGlioblastomaNeoplasms, NeuroepithelialOptic Nerve GliomaMedulloblastomaFamilial ependymomaEpendymomaMeningiomaChoroid Plexus NeoplasmsCraniopharyngiomaNeuroectodermal Tumors, PrimitiveGliosarcomaPinealomaGlioma, Subependymal

Interventions

Verteporfin

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesGliomaNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueOptic Nerve NeoplasmsCranial Nerve NeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesOptic Nerve DiseasesEye DiseasesNeoplasms, Vascular TissueMeningeal NeoplasmsCerebral Ventricle Neoplasms

Intervention Hierarchy (Ancestors)

PorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Harry T. Whelan, MD

    Medical College of Wisconsin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

May 1, 1994

Last Updated

September 20, 2013

Record last verified: 2009-06

Locations

US(2)