- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003461
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors
Phase I Study of At-Labeled Anti-Tenascin Human/Mouse Chimeric Monoclonal Antibody 81C6 (ch81C6) Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary or Metastatic Brain Tumors
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. This may be effective treatment for primary or metastatic brain tumors.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients with primary or metastatic brain tumors.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the toxicity of monoclonal antibody (MAb) Astatine At 211 Antitenascin Human/Mouse Chimeric 81C6 (At 211 MAb 81C6) therapy delivered via the intracranial resection cavity in patients with recurrent primary or metastatic malignant brain tumors.
- Identify objective therapeutic responses of these patients to this treatment.
OUTLINE: This is a dose escalation study.
Patients undergo surgical resection of their tumor at which time an indwelling intracranial resection cavity catheter is surgically placed. Patients receive one dose of astatine At 211 antitenascin monoclonal antibody 81C6 (At 211 MAb 81C6) via the intralesional catheter.
Cohorts of 3-6 patients are treated at escalating doses of At 211 MAb 81C6. The maximum tolerated dose is the highest dose at which no more than 3 of 6 patients experience dose limiting toxicity.
Patients are followed initially at 4 weeks, then at approximately 12 weeks, at 24 weeks, and then every 12 weeks for 1 year.
PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 18-24 months.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed or recurrent supratentorial primary or metastatic malignant brain tumor
Measurable disease by MRI or CT scan
- Candidate for surgical resection
- Extension of tumor no more than 1.0 cm beyond the margin of the surgical cavity
- Demonstrated reactivity of tumor cells with tenascin by immunohistology with either a polyclonal rabbit antibody or the monoclonal mouse antibody
- No infratentorial tumors, diffusely infiltrating tumors, tumors with subependymal spread, or multifocal tumors
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
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 6 weeks since prior chemotherapy, unless unequivocal evidence of progression
Endocrine therapy:
- Concurrent corticosteroids allowed, but must be on stable dose for at least 1 week
Radiotherapy:
- At least 3 months since prior radiotherapy to site of measurable disease in the CNS
Surgery:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- recurrent adult brain tumor
- adult anaplastic astrocytoma
- tumors metastatic to brain
- adult central nervous system germ cell tumor
- adult craniopharyngioma
- adult medulloblastoma
- adult meningioma
- adult oligodendroglioma
- adult grade III meningioma
- adult mixed glioma
- adult pilocytic astrocytoma
- recurrent neuroblastoma
- adult pineal gland astrocytoma
- adult pineal parenchymal tumor
- localized resectable neuroblastoma
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Brain Neoplasms
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Neuroblastoma
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
- Antibodies, Monoclonal
Other Study ID Numbers
- 2237
- DUMC-2237-01-12R4
- DUMC-0013-00-1R2
- DUMC-0036-99-1R1
- DUMC-060-98-1
- DUMC-2237-00-12R3
- DUMC-98007
- NCI-5P50NS20023
- NCI-G98-1462
- CDR0000066493
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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