NCT00118222

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

June 11, 2010

Status Verified

June 1, 2010

Enrollment Period

1 year

First QC Date

July 8, 2005

Last Update Submit

June 9, 2010

Conditions

Brain and Central Nervous System Tumors

Keywords

adult mixed gliomaadult anaplastic astrocytomarecurrent adult brain tumoradult giant cell glioblastomaadult gliosarcoma

Outcome Measures

Primary Outcomes (1)

  • Time to progression and survival measured

    at 4-6 weeks post-operatively and then every 3-4 months thereafter

Study Arms (2)

Low light dose during surgery

ACTIVE COMPARATOR

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

Drug: porfimer sodiumProcedure: adjuvant therapyProcedure: conventional surgery

High light dose during surgery

ACTIVE COMPARATOR

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

Drug: porfimer sodiumProcedure: adjuvant therapyProcedure: conventional surgery

Interventions

porfimer sodiumDRUG

All patients receive porfimer sodium IV.

Also known as: dihematoporphyrin ether, Photofrin II, Porfimer
High light dose during surgeryLow light dose during surgery
adjuvant therapyPROCEDURE

All patients receive porfimer sodium IV.

Also known as: dihematoporphyrin ether, Photofrin II, Porfimer
High light dose during surgeryLow light dose during surgery
conventional surgeryPROCEDURE

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

High light dose during surgeryLow light dose during surgery

Eligibility Criteria

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

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

Sponsors & Collaborators

Study Sites (1)

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

Cleveland, Ohio, 44106-5000, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsGliomaAstrocytomaBrain NeoplasmsGlioblastomaGliosarcoma

Interventions

Dihematoporphyrin EtherChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hematoporphyrin DerivativeHematoporphyrinsPorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsPigments, BiologicalBiological FactorsCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Robert J. Maciunas, MD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2005

First Posted

July 11, 2005

Study Start

March 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

June 11, 2010

Record last verified: 2010-06

Locations

US(1)