NCT00409214

CompletedPhase 2

Phase IIa Safety and Light Dose-escalation Study in Patients...

NCT00409214|CompletedPhase 2

Phase IIa Safety and Light Dose-escalation Study in Patients With Primary or Recurrent/High-grade Glioma Using the Litx™ System to Confirm the Zone of Tumor Destruction During the Intraoperative Treatment of Glioma

A Phase IIa Safety and Light Dose-escalation Study in Patients With Primary or Recurrent/High-grade Glioma (Defined for the Purposes of the Protocol as Anaplastic Astrocytoma [AA] or Glioblastoma Multiforme [GBM]) Using the Litx™ System to Confirm the Zone of Tumor Destruction During the Intraoperative Treatment of Glioma

Light Sciences Oncology

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

LSO-OL007

Study Type

interventional

Estimated enrollment

18

Locations

1 country

Sites

1

Timeline

Study Start

November 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2008

Actual (reported)

Study Completion

Not reported

Date not reported

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 18 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
December 7, 2006
Actual (reported)
First Posted
December 8, 2006
Actual (reported)
Primary Completion
February 2008
Actual (reported)

Last Updated: November 16, 2012
Status Verified: November 2012
Last Update Submitted: November 14, 2012

Conditions

Anaplastic Astrocytoma Glioblastoma Multiforme Glioma

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

Sponsors & Collaborators

Light Sciences Oncology
Industrylead

Study Sites (1)

Institute of Neurosurgery, Clinical Centre Serbia

Belgrade, Serbia

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 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2008

Actual (reported)

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Phase 2Completed

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Phase 2Unknown

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Phase 2Completed

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Phase 2Unknown

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Phase 2Unknown

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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Last Updated

November 16, 2012

Record last verified: 2012-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00409214
Data provider: ClinicalTrials.gov
Source updated: 2012-11-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:41 UTC

Locations

RS(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations