Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors

NCT ID: NCT00003484

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-09-30
• Study Completion Date: 2010-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Brain and Central Nervous System Tumors; Neuroblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

carmustine

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

surgical procedure

Intervention Type: PROCEDURE

iodine I 131 monoclonal antibody 81C6

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Darell D. Bigner, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Darell D. Bigner, MD, PhD

Director, The Preston Robert Tisch Brain Tumor Center at Duke

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Darell D. Bigner, MD, PhD

Role: STUDY_CHAIR

Duke University

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

DUMC-1533-02-8R5ER

Identifier Type: OTHER

Identifier Source: secondary_id

DUMC-1533-01-8R4

Identifier Type: OTHER

Identifier Source: secondary_id

DUMC-1373-97-9

Identifier Type: OTHER

Identifier Source: secondary_id

DUMC-1408-98-9R1

Identifier Type: OTHER

Identifier Source: secondary_id

DUMC-1533-00-8R3

Identifier Type: OTHER

Identifier Source: secondary_id

DUMC-1570-99-9R2

Identifier Type: OTHER

Identifier Source: secondary_id

DUMC-97107

Identifier Type: OTHER

Identifier Source: secondary_id

5P0NS20023

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCI-G98-1472

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDR0000066522

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00008915

Identifier Type: -

Identifier Source: org_study_id