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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Light Sciences Oncology
• Treatments: Talaporfin

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