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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00752323 |
RATIONALE: Imaging procedures that use aminolevulinic acid may help find and diagnose residual tumor in patients with grade IV malignant astrocytoma who are undergoing surgery to remove the tumor.
PURPOSE: This randomized phase II trial is studying the best dose of aminolevulinic acid when given before an imaging procedure in finding residual tumor in patients with grade IV malignant astrocytoma who are undergoing surgery.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: aminolevulinic acid |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized |
Official Title: | Fluorescence-Guided Detection of Malignant Gliomas: A Dose Ranging Study Using 5-Aminolevulinic Acid (ALA) Induced Protoporphyrin (PpIX) in a Multicenter Phase II Clinical Trial |
Estimated Enrollment: | 90 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive low-dose oral aminolevulinic acid at 2 hours before the midpoint of surgery.
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Drug: aminolevulinic acid
Given orally
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Arm II: Experimental
Patients receive low-dose oral aminolevulinic acid at 6 hours before the midpoint of surgery.
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Drug: aminolevulinic acid
Given orally
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Arm III: Experimental
Patients receive low-dose oral aminolevulinic acid at 12 hours before the midpoint of surgery.
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Drug: aminolevulinic acid
Given orally
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Arm IV: Experimental
Patients receive medium-dose oral aminolevulinic acid at 2 hours before the midpoint of surgery.
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Drug: aminolevulinic acid
Given orally
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Arm V: Experimental
Patients receive medium-dose oral aminolevulinic acid at 6 hours before the midpoint of surgery.
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Drug: aminolevulinic acid
Given orally
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Arm VI: Experimental
Patients receive medium-dose oral aminolevulinic acid at 12 hours before the midpoint of surgery.
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Drug: aminolevulinic acid
Given orally
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Arm VII: Experimental
Patients receive high-dose oral aminolevulinic acid at 2 hours before the midpoint of surgery.
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Drug: aminolevulinic acid
Given orally
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Arm VIII: Experimental
Patients receive high-dose oral aminolevulinic acid at 6 hours before the midpoint of surgery.
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Drug: aminolevulinic acid
Given orally
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Arm IX: Experimental
Patients receive high-dose oral aminolevulinic acid at 12 hours before the midpoint of surgery.
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Drug: aminolevulinic acid
Given orally
|
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study. Patients are stratified according to clinical site and disease status (de novo vs recurrent). Patients are randomized to 1 of 9 treatment arms.
Patients in all arms undergo quantitative fluorescence imaging of tumor tissue and normal tissue at approximately the midpoint of surgery and then after maximal resection of the tumor. Tumor tissue samples are obtained at the same two timepoints of fluorescence imaging and are analyzed for histopathology, PpIX quantification by spectrofluorimetry, and PpIX microdistribution by confocal fluorescence microscopy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of supratentorial malignant astrocytoma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Ohio | |
Case Comprehensive Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44106-5065 | |
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
Geauga Regional Hospital | Recruiting |
Cleveland, Ohio, United States, 44024 | |
Contact: Robert Maciunas 216-844-5743 | |
Lake/University Ireland Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44060 | |
Contact: Robert Maciunas 216-844-5743 | |
Mercy Cancer Center at Mercy Medical Center | Recruiting |
Cleveland, Ohio, United States, 44708 | |
Contact: Robert Maciunas 216-844-5743 | |
University Suburban Health Center | Recruiting |
Cleveland, Ohio, United States, 44121 | |
Contact: Robert Maciunas 216-844-5743 | |
UHHS Chagrin Highlands Medical Center | Recruiting |
Cleveland, Ohio, United States, 44122 | |
Contact: Robert Maciunas 216-844-5743 | |
UHHS Westlake Medical Center | Recruiting |
Cleveland, Ohio, United States, 44145 | |
Contact: Robert Maciunas 216-844-5743 | |
Southwest General Health Center | Recruiting |
Cleveland, Ohio, United States, 44130 | |
Contact: Robert Maciunas 216-844-5743 |
Principal Investigator: | Robert J. Maciunas, MD | Case Comprehensive Cancer Center |
Responsible Party: | Case Comprehensive Cancer Center ( Robert J. Maciunas ) |
Study ID Numbers: | CDR0000613087, CASE-1305 |
Study First Received: | September 12, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00752323 History of Changes |
Health Authority: | Unspecified |
adult giant cell glioblastoma adult glioblastoma adult gliosarcoma recurrent adult brain tumor |
Glioblastoma Astrocytoma Central Nervous System Neoplasms Recurrence Aminolevulinic Acid Brain Neoplasms Signs and Symptoms |
Photosensitizing Agents Malignant Astrocytoma Radiation-Sensitizing Agents Glioma Gliosarcoma Nervous System Neoplasms |
Photosensitizing Agents Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Physiological Effects of Drugs |
Nervous System Diseases Central Nervous System Neoplasms Dermatologic Agents Pharmacologic Actions Nervous System Neoplasms Aminolevulinic Acid |