A Phase 1/2 interventional study of cintredekin besudotox and isolated perfusion in Brain and Central Nervous System Tumors, sponsored by New Approaches to Brain Tumor Therapy Consortium. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-24.
Sponsored by New Approaches to Brain Tumor Therapy Consortium · Phase 1/2, Interventional, and Treatment
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.
OBJECTIVES:
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.
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
Browse Glioma studies →New Approaches to Brain Tumor Therapy Consortium is the lead sponsor of 11 studies on the registry; none are open to participants now.
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DISEASE CHARACTERISTICS:
Histologically proven malignant glioma (grade 3 or 4)
Must have radiographic evidence of recurrent or progressive supratentorial tumor compared with prior study
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
This study is completed, as verified in Mar 2005. You cannot join it, but the record below documents what was studied.
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New Approaches to Brain Tumor Therapy Consortium