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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

Primary Purpose

Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma

Status

Completed

Phase

Phase 2

Locations

Serbia

Study Type

Interventional

Intervention

LS11 (talaporfin sodium)

Light source (interstitial light emitting diodes)

Intraoperative placement of device in glioma

About this trial

This is an interventional treatment trial for Glioma focused on measuring Glioma, Litx™, LS11, Glioblastoma multiforme, Anaplastic Astrocytoma, GBM, AA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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

Sites / Locations

Institute of Neurosurgery, Clinical Centre Serbia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00409214

First Posted

December 7, 2006

Last Updated

November 14, 2012

Sponsor

Light Sciences Oncology

1. Study Identification

Unique Protocol Identification Number

NCT00409214

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Light Sciences Oncology

4. Oversight

5. Study Description

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.

Detailed Description

Light Infusion Technology (Litx™) is a locoregional cancer treatment in which a systemically administered light-activated drug (LS11) is activated locally by illuminating the diseased tissue using light-emitting diodes (LEDs) of a specific wavelength. The activated photosensitizer reacts with endogenous oxygen to yield highly reactive species of oxygen that cause destruction of cellular structures such as mitochondria, lysosomes and cell walls leading to irreversible cell damage and tissue death. Either twenty-four or twelve hours prior to surgery, the patient will receive an intravenous dose of 1 mg/kg of LS11, given IV by slow push over 3-5 minutes. Following craniotomy, patients will undergo intraoperative placement of a single Light Source, centrally placed within the tumor, under direct visualization prior to tumor resection. Following placement of the light source (with the depth of the end of the light bar from the cortical surface to be calculated from the pre-operative MRI and spiral CT scan, so as to be centralized within the main tumor bulk), light will be delivered following a predetermined escalation schedule (either 100 J/cm or 200 J/cm) at 20 mW/cm light energy for a treatment time of 1 hour 24 minutes (100J/cm) or 2 hours 46 minutes (200 J/cm). The Light Source will then be manually removed and the tumor maximally resected. The resected tumor and marginal tissue will be submitted for pathology to determine depth of cell death, extent of tumor tissue containing closed vessels, any evidence of vessel closure or other damage to tissues outside of the projected kill zone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma

Keywords

Glioma, Litx™, LS11, Glioblastoma multiforme, Anaplastic Astrocytoma, GBM, AA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

LS11 (talaporfin sodium)

Intervention Type

Device

Intervention Name(s)

Light source (interstitial light emitting diodes)

Intervention Type

Procedure

Intervention Name(s)

Intraoperative placement of device in glioma

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sy-Shi Wang, PhD

Organizational Affiliation

Light Sciences Oncology

Official's Role

Study Director

Facility Information:

Facility Name

Institute of Neurosurgery, Clinical Centre Serbia

City

Belgrade

Country

Serbia

12. IPD Sharing Statement

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