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

NCT ID: NCT00003461

Last Updated: 2014-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-02-28
• Study Completion Date: 2005-02-28

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.

Conditions

Brain and Central Nervous System Tumors; Metastatic Cancer; Neuroblastoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

surgical procedure

Intervention Type: PROCEDURE

astatine At 211 monoclonal antibody 81C6

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darell D. Bigner, MD, PhD

Role: STUDY_CHAIR

Duke Cancer Institute

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

DUMC-2237-01-12R4

Identifier Type: -

Identifier Source: secondary_id

DUMC-0013-00-1R2

Identifier Type: -

Identifier Source: secondary_id

DUMC-0036-99-1R1

Identifier Type: -

Identifier Source: secondary_id

DUMC-060-98-1

Identifier Type: -

Identifier Source: secondary_id

DUMC-2237-00-12R3

Identifier Type: -

Identifier Source: secondary_id

DUMC-98007

Identifier Type: -

Identifier Source: secondary_id

NCI-5P50NS20023

Identifier Type: -

Identifier Source: secondary_id

NCI-G98-1462

Identifier Type: -

Identifier Source: secondary_id

CDR0000066493

Identifier Type: -

Identifier Source: secondary_id

2237

Identifier Type: -

Identifier Source: org_study_id