Spots Global Cancer Trial Database for Immunotoxin Therapy in Treating Patients With Malignant Glioma
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Trial Identification
Brief Title: Immunotoxin Therapy in Treating Patients With Malignant Glioma
Official Title: Interstitial Infusion of IL 13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study
Study ID: NCT00006268
Conditions
Study Description
Brief Summary: RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for malignant glioma. PURPOSE: Phase I/II trial to study the effectiveness of immunotoxin therapy in treating patients who have malignant glioma.
Detailed Description: OBJECTIVES: * Determine the toxic effects and maximum tolerated dose (MTD) of interstitial interleukin-13 PE38QQR immunotoxin in patients with malignant glioma. * Determine the response rate, duration of response, time to response, overall survival, and time to progression in patients treated with this regimen. * Determine the toxic effects of this drug at the MTD in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients undergo stereotactic biopsy of brain tumor followed by CT guided stereotactic placement of 2 intratumoral catheters on day 0. Patients with histologically confirmed malignant glioma receive interleukin-13 PE38QQR immunotoxin interstitially over 96 hours beginning on day 1. Patients with a residual enhancing mass undergo repeat catheter placement on day 56 and then receive a second interstitial infusion beginning on day 57 in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of interleukin-13 PE38QQR immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for phase I of the study within 6 months and a total of 12-35 patients will be accrued for phase II of the study within 10-12 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States
National Institute of Neurological Disorders and Stroke, Bethesda, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Contact Details
Name: Jon Weingart, MD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: STUDY_CHAIR
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