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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Darell D. Bigner, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00003484
First received: November 1, 1999
Last updated: December 12, 2012
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by Duke University:

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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003484

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Darell D. Bigner
Investigators
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
Central Nervous System Neoplasms
Neoplasms
Nervous System Neoplasms
Neuroblastoma
Brain Diseases
Central Nervous System Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Antibodies
Antibodies, Monoclonal
Immunoglobulins
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014