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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Duke University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003484
  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: iodine I 131 monoclonal antibody 81C6
Drug: irinotecan hydrochloride
Procedure: surgical procedure
Phase I
Phase II

MedlinePlus related topics:   Brain Cancer    Cancer    Neuroblastoma   

ChemIDplus related topics:   Carmustine    Irinotecan    Irinotecan hydrochloride    Iodine    Cadexomer iodine    Sodium iodide I 131   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   41
Study Start Date:   September 1997

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

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

Investigators
Study Chair:     Darell D. Bigner, MD, PhD     Duke University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066522, 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, NCI-5P0NS20023, NCI-G98-1472
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003484
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized resectable neuroblastoma  
recurrent adult brain tumor  
adult craniopharyngioma  
adult medulloblastoma  
adult meningioma  
adult glioblastoma  
adult oligodendroglioma  
adult anaplastic astrocytoma  
mixed gliomas
adult pineal parenchymal tumor
adult central nervous system germ cell tumor
adult grade III meningioma
adult pilocytic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:
Glioblastoma
Neuroectodermal Tumors, Primitive
Irinotecan
Central Nervous System Neoplasms
Brain Diseases
Neuroblastoma
Antibodies, Monoclonal
Neoplasms, Germ Cell and Embryonal
Craniopharyngioma
Neuroepithelioma
Iodine
Meningioma
Glioma
Nervous System Neoplasms
Astrocytoma
Carmustine
Central Nervous System Diseases
Camptothecin
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Antibodies
Medulloblastoma
Oligodendroglioma
Gliosarcoma
Pinealoma
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on September 19, 2008




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