Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors
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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 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label 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 |
| Enrollment: | 21 |
| Study Start Date: | September 1997 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the toxicity of iodine I 131 monoclonal antibody 81C6 delivered via the intracranial resection cavity in patients with newly diagnosed primary malignant brain tumors after surgery and radiotherapy.
- Determine objective therapeutic responses of these patients to this treatment.
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:
- Histologically confirmed newly diagnosed supratentorial primary malignant brain tumor
- No infratentorial tumors, infiltrating tumors, tumors with subependymal spread, or multifocal tumors
- Candidate for surgical resection
- Prior external beam radiotherapy to site of measurable disease or resection site in the nervous system required
- Presence of tenascin in the tumor demonstrated by immunohistology with either a polyclonal rabbit antitenascin antibody or monoclonal antibody 81C6
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 50-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- Alkaline phosphatase less than 1.5 times normal
- Lactic dehydrogenase less than 1.5 times normal
- SGOT less than 1.5 times normal
Renal:
- Creatinine less than 1.2 mg/dL
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No iodine allergies
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Concurrent corticosteroids allowed, but must be on stable dose for at least 10 days
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
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
Additional Information:
No publications provided
| Responsible Party: | Darell D. Bigner, Director, The Preston Robert Tisch Brain Tumor Center at Duke, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00003484 History of Changes |
| Other Study ID Numbers: | Pro00008915, 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, 5P0NS20023, NCI-G98-1472, CDR0000066522 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Duke University:
|
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 |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 21, 2013