NCT00003788

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.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
270

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
2 countries

4 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
1.6 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

November 6, 2013

Status Verified

September 1, 2003

First QC Date

November 1, 1999

Last Update Submit

November 5, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult anaplastic astrocytomaadult giant cell glioblastomaadult gliosarcoma

Interventions

carmustineDRUG
lomustineDRUG
porfimer sodiumDRUG
procarbazine hydrochlorideDRUG
neoadjuvant therapyPROCEDURE
surgical procedurePROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

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

Sponsors & Collaborators

Study Sites (4)

Rocky Mountain Neurological Associates

Englewood, Colorado, 80110, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

St. Michael's Hospital-Annex

Toronto, Ontario, M5B 1A6, Canada

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaGliosarcoma

Interventions

CarmustineLomustineDihematoporphyrin EtherProcarbazineNeoadjuvant TherapySurgical Procedures, OperativeRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsHematoporphyrin DerivativeHematoporphyrinsPorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsPigments, BiologicalBiological FactorsBenzamidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCombined Modality TherapyTherapeutics

Study Officials

  • Fred W. Hetzel, PhD, JD

    Colorado Health Foundation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

April 1, 1998

Last Updated

November 6, 2013

Record last verified: 2003-09

Locations

US(3)CA(1)