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

Study Purpose

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have primary or metastatic brain cancer.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 3 Years and Over
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Histologically proven primary or metastatic malignant supratentorial anaplastic glioma.
  • - Newly diagnosed or recurrent.
  • - No diffusely infiltrating or multifocal tumor.
  • - No tumor with subependymal spread.
  • - Resection of glioma and placement of an intralesional catheter into the surgical cavity required before study.
  • - Measurable lesion on enhanced CT scan or MRI.
  • - No measurable enhancing lesion greater than 1.0 cm beyond cavity margin.
  • - Neoplastic cell reactivity with tenascin demonstrated by immunohistology with either a polyclonal rabbit antibody or a monoclonal murine antibody.
PATIENT CHARACTERISTICS: Age:
  • - 3 and over.
Performance status:
  • - Karnofsky 50-100% Hematopoietic: - Absolute neutrophil count greater than 1,000/mm^3.
  • - Platelet count greater than 100,000/mm^3.
Hepatic:
  • - Bilirubin less than 1.5 mg/dL.
  • - AST less than 1.5 times normal.
  • - Alkaline phosphatase less than 1.5 times normal.
Renal:
  • - Creatinine less than 1.2 mg/dL.
Other:
  • - Not pregnant.
  • - Negative pregnancy test.
  • - 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 tumor progression.
Endocrine therapy:
  • - Corticosteroids allowed if at lowest possible dose and dose stable for at least 10 days prior to entry.
Radiotherapy:
  • - At least 3 months since prior radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression.
Surgery: - See Disease Characteristics

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00002752
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Darell D. Bigner, MD, PhD
Principal Investigator Affiliation Duke Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors, Metastatic Cancer
Additional Details

OBJECTIVES:

  • - Determine the toxic effects of intracranial iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 in patients with primary or metastatic anaplastic gliomas.
  • - Determine the objective therapeutic response of these patients treated with this regimen.
OUTLINE: This is a dose escalation study of iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 (MOAB 81C6). Patients are stratified by prior external beam radiotherapy (yes vs.#46;no). Patients receive iodine I 131 labeled MOAB 81C6 intraventricularly followed by unlabeled MOAB 81C6 intraventricularly. Cohorts of 3-6 patients receive escalating doses of iodine I 131 labeled MOAB 81C6 until the maximum tolerated dose is determined. The MTD is defined as the highest dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. Patients are followed monthly for 2 years, every 2 months for 2 years, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 3-6 patients per cohort will be accrued for this study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke Comprehensive Cancer Center, Durham, North Carolina

Status

Address

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710

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