Brain and Central Nervous System TumorsPhase 1/2NCT00002752
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers
A Phase 1/2 study testing iodine I 131 monoclonal antibody 81C6 in people with Brain and Central Nervous System Tumors and Metastatic Cancer, run by Duke University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Metastatic Cancer
- What is being tested?
- iodine I 131 monoclonal antibody 81C6
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 1993to Mar 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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 locations and contacts
1 site in 1 country.
United States1 site
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
About this study
Official title: PHASE I STUDY OF ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT BRAIN TUMORS
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.
Read the detailed description
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 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.
- Being tested
- iodine I 131 monoclonal antibody 81C6
- Keywords
- childhood supratentorial ependymoma, recurrent childhood brain tumor, recurrent adult brain tumor, adult medulloblastoma, adult glioblastoma, tumors metastatic to brain, childhood high-grade cerebral astrocytoma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult pilocytic astrocytoma, adult subependymoma, adult ependymoblastoma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, newly diagnosed childhood ependymoma
- Medical subject headings
- Central Nervous System Neoplasms, Neoplasm Metastasis, Brain Neoplasms, Medulloblastoma, Glioblastoma, Astrocytoma, Ependymoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iodine I 131 monoclonal antibody 81C6Radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2003 (estimated)
- Study startFeb 1993
- Primary completionJan 2003
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darell D. Bigner, MD, PhD, Study chair, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002752
- Sponsor's protocol ID
- Pro00004635
- Other IDs
- DUMC-2426-01-2R8, DUMC-000223-00-2R7, DUMC-0328-99-2R6, DUMC-221-96-2R3, DUMC-307-97-2R4, DUMC-307-98-2R5, NCI-H96-0009, CDR0000064688
- Status last verified
- Feb 2013
- First submitted
- 1 Nov 1999
- Last updated
- 16 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE I STUDY OF ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT BRAIN TUMORS
- ClinicalTrials.gov ID
- NCT00002752
- Acronym / sponsor ID
- Pro00004635
- Keywords
- childhood supratentorial ependymoma, recurrent childhood brain tumor, recurrent adult brain tumor, adult medulloblastoma, adult glioblastoma, tumors metastatic to brain, childhood high-grade cerebral astrocytoma, adult anaplastic astrocytoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Feb 1993
- Primary completion
- Jan 2003 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 8 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iodine I 131 monoclonal antibody 81C6 | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darell D. Bigner, MD, PhD study chair
Duke Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing iodine I 131 monoclonal antibody 81C6 in people with Brain and Central Nervous System Tumors and Metastatic Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.