WithdrawnPhase 2

More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery

United States0Started 2015-11

Plain-language summary

The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When the investigators remove the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red under blue light. This may make it easier for your doctor to take out all of the tumor from your brain. The purpose of this study is to: * Make sure that 5-ALA helps the doctor remove more of the tumor. * Make sure 5-ALA does not cause any side effects. If you do not want to participate in this study, your doctor(s) will still do their best to remove all of the tumor in your brain. Whether or not you join this study will not change your treatment for your brain tumor.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects must have a clinically documented primary brain tumor for which resection is clinically indicated. Individuals with suspected newly diagnosed or recurrent malignant gliomas will be considered eligible for the study. The anticipated histology at resection should include: Anaplastic astrocytoma (10002224), Anaplastic ependymoma, Anaplastic oligodendroglioma, Astrocytoma malignant NOS (10003572), Glioblastoma (10018336), Glioblastoma multiforme (10018337), or Gliosarcoma (10018340). * Prior therapy is not a consideration in protocol entry. * Age 18-80. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%). * Life expectancy is not a consideration for protocol entry. * Subjects must have normal organ and marrow function as defined below: * Leukocytes ≥ 3,000/mL * Platelets ≥ 100,000/mL * Total bilirubin below upper limit of normal * Aspartate aminotransferase (AST) (SGOT)/alanine aminotransferase (ALT) (SGPT) ≤ 2.5 X institutional upper limit of normal * Creatinine below upper limit of normal OR * Creatinine clearance ≥ 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal * The effects of aminolevulinic acid (ALA) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Sh…

What they're measuring

Radicality of Brain Tumor Resection

Timeframe: Within the first 48 hours after surgery

Trial details

NCT IDNCT01445691

SponsorConstantinos Hadjipanayis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09