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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors

Primary Purpose

Brain and Central Nervous System Tumors, Metastatic Cancer, Neuroblastoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
surgical procedure
astatine At 211 monoclonal antibody 81C6
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring localized resectable neuroblastoma, recurrent neuroblastoma, recurrent adult brain tumor, adult craniopharyngioma, adult medulloblastoma, adult meningioma, adult glioblastoma, adult oligodendroglioma, tumors metastatic to brain, 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, adult pineal gland astrocytoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
August 20, 2014
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003461
Brief Title
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Metastatic Cancer, Neuroblastoma
Keywords
localized resectable neuroblastoma, recurrent neuroblastoma, recurrent adult brain tumor, adult craniopharyngioma, adult medulloblastoma, adult meningioma, adult glioblastoma, adult oligodendroglioma, tumors metastatic to brain, 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, adult pineal gland astrocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
surgical procedure
Intervention Type
Radiation
Intervention Name(s)
astatine At 211 monoclonal antibody 81C6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darell D. Bigner, MD, PhD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors

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