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

Study 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.

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 18 Years and Over
Gender All
More Inclusion & Exclusion 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

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.

 NCT00003484
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
Lead Sponsor

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

 Darell D. Bigner, MD, PhD
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 University
Agency Class

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

 Other, NIH
Overall Status Completed
Countries United States
Conditions

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

 Brain and Central Nervous System Tumors, Neuroblastoma
Additional Details

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.

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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