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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00036972 |
RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating malignant glioma.
PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy before and after surgery in treating patients who have recurrent malignant glioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: cintredekin besudotox Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study to Assess the Histologic Effect and Safety of Pre-Operative and Post-Operative Infusions of IL13-PE38QQR Cytotoxin in Patients With Recurrent Resectable Supratentorial Malignant Glioma |
Study Start Date: | November 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study.
Cohorts of 3-6 patients receive escalating doses of pre-resection interleukin-13 PE38QQR immunotoxin until the histologically effective concentration (HEC) is reached or maximum tolerated dose (MTD) is determined. The HEC is defined by pathologic observations. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. After the HEC is reached or MTD is determined, up to 6 additional patients are enrolled at selected dose levels to study safety and tolerability. Subsequent cohorts of patients are not treated with a pre-resection infusion.
Cohorts of 3-6 patients receive escalating doses of interleukin-13 PE38QQR immunotoxin until the previously-defined HEC is reached or MTD is determined, whichever occurs first. If dose-escalation is stopped after HEC is reached, then three additional cohorts of patients receive escalating durations (5, 6, or 7 days) of post-resection infusion. If dose escalation is stopped after the MTD is determined, then the duration of post-resection infusion is not escalated.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed supratentorial malignant glioma (grade 3 or 4)
Radiographic evidence of recurrent or progressive supratentorial tumor
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Lauren E. Abrey, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000069345, MSKCC-01141, NEOPHARM-IL13PEI-002-R01, NCI-G02-2066 |
Study First Received: | May 13, 2002 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00036972 |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma |
adult mixed glioma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Central Nervous System Neoplasms Recurrence Immunotoxins Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Nervous System Diseases Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |