NCT00409214

Brief Summary

The pupose of this study is to demonstrate the safety of the Litx™ therapy and confirm the zone of tumor destruction with escalated light doses following intraoperative treatment of primary or recurrent glioma.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2

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

November 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Last Updated

November 16, 2012

Status Verified

November 1, 2012

Enrollment Period

1.3 years

First QC Date

December 7, 2006

Last Update Submit

November 14, 2012

Conditions

GliomaGlioblastoma MultiformeAnaplastic Astrocytoma

Keywords

GliomaLitx™LS11Glioblastoma multiformeAnaplastic AstrocytomaGBMAA

Outcome Measures

Primary Outcomes (1)

  • To demonstrate the safety of the Litx™ therapy and confirm the zone of tumor destruction with escalated light doses following intraoperative treatment of primary or recurrent glioma

Interventions

LS11 (talaporfin sodium)DRUG
Light source (interstitial light emitting diodes)DEVICE
Intraoperative placement of device in gliomaPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Have primary or recurrent glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA) undergoing planned tumor resection
  • Have a right sided, supratentorial frontal or temporal lobe tumor
  • Have right hand dominance
  • Be adults aged \>18 years
  • Have a Karnofsky Performance Status score \>70
  • Have a estimated life expectancy of \>12 weeks
  • Have completed any prior antineoplastic therapy at least 4 weeks prior to surgery and be recovered from acute side effects
  • Must have the understanding and ability to sign an informed consent document
  • Be male or non-pregnant, non-lactating females. Patients who are fertile must agree to use an effective method of contraception during participation in the study
  • Have a negative serum or urine pregnancy test within 14 days prior to treatment (if patient is a female of childbearing potential).

You may not qualify if:

  • Patients must be excluded if any of the following apply:
  • Have tumors \<2 cm in diameter
  • Have inadequate organ function as evidenced by: PT or PTT \>1.5 × control ; Platelet count \<100,000/mm3 ; WBC \<2,500/mm3 ; Neutrophils \<2000/mm3 ; Hemoglobin \<9 g/dL
  • Be concurrently participating in another clinical trial involving experimental treatment
  • Have any concurrent diseases or conditions that in the opinion of the investigator impair the patient's ability to complete the trial such as psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data are excluded.
  • Have psychological, familial, sociological, geographical, or medical conditions which, in the Investigator's opinion, could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial data.
  • Have a known sensitivity to porphyrin-type drugs or known history of porphyria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Neurosurgery, Clinical Centre Serbia

Belgrade, Serbia

Location

MeSH Terms

Conditions

GliomaGlioblastomaAstrocytoma

Interventions

Talaporfin

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Sy-Shi Wang, PhD

    Light Sciences Oncology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 8, 2006

Study Start

November 1, 2006

Primary Completion

February 1, 2008

Last Updated

November 16, 2012

Record last verified: 2012-11

Locations

SE(1)