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| Sponsor: | Duke University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003484 |
Purpose
RATIONALE: Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances, such as radioactive iodine, to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody after radiation therapy in treating patients with newly diagnosed primary brain tumors that can be surgically resected.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Neuroblastoma |
Drug: carmustine Drug: irinotecan hydrochloride Procedure: surgical procedure Radiation: iodine I 131 monoclonal antibody 81C6 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Study of Anti-Tenascin Monoclonal Antibody I-Labeled 81C6 Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary Brain Tumors After External Beam Radiotherapy |
| Estimated Enrollment: | 41 |
| Study Start Date: | September 1997 |
OBJECTIVES:
OUTLINE: This is a dose escalation study of iodine I 131 antitenascin monoclonal antibody 81C6 (I 131 MAb 81C6).
Within 2-4 weeks after completion of external beam radiotherapy, patients undergo surgical resection of the tumor or brain metastasis, at which time an indwelling intracranial resection cavity catheter is placed. A single dose of I 131 MAb 81C6 is delivered via the intralesional catheter.
Cohorts of 3-6 patients receive escalating doses of I 131 MAb 81C6 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
After the MTD has been established, patients in the phase II portion of the study receive therapy as in phase I.
Beginning 4 weeks after the monoclonal antibody treatment, patients begin chemotherapy. Patients receive carmustine IV over 1 hour on day 1 and irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment is repeated every 6 weeks for at least 4 courses in the absence of disease progression.
Patients are followed initially at 4 weeks, then every 6 weeks for 1 year.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Study Chair: | Darell D. Bigner, MD, PhD | Duke University |
More Information
| ClinicalTrials.gov Identifier: | NCT00003484 History of Changes |
| Other Study ID Numbers: | CDR0000066522, DUMC-1533-02-8R5ER, DUMC-1533-01-8R4, DUMC-1373-97-9, DUMC-1408-98-9R1, DUMC-1533-00-8R3, DUMC-1570-99-9R2, DUMC-97107, NCI-5P0NS20023, NCI-G98-1472 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
|
localized resectable neuroblastoma recurrent adult brain tumor adult craniopharyngioma adult medulloblastoma adult meningioma adult glioblastoma adult oligodendroglioma adult anaplastic astrocytoma |
adult mixed glioma adult pineal parenchymal tumor adult central nervous system germ cell tumor adult grade III meningioma adult pilocytic astrocytoma adult giant cell glioblastoma adult gliosarcoma |
|
Brain Neoplasms Nervous System Neoplasms Neuroblastoma Central Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Antibodies Immunoglobulins Antibodies, Monoclonal Carmustine Irinotecan Camptothecin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
