Brain and Central Nervous System TumorsPhase 1NCT00002753
Monoclonal Antibody Therapy in Treating Patients With Recurrent Gliomas
A Phase 1 study testing iodine I 131 monoclonal antibody 81C6 in people with Brain and Central Nervous System Tumors, run by Duke University at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to determine the effectiveness of monoclonal antibody in treating patients with recurrent gliomas. 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
- What is being tested?
- iodine I 131 monoclonal antibody 81C6
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1991to Apr 2001
- Phase
- Phase 1
- 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 confirmed supratentorial anaplastic glioma with a recurrent cyst requiring aspiration for symptom control Measurable cystic lesion confirmed by contrast-enhanced CT or MRI At least 3 months since radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression 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/mm3 Platelet count greater than 100,000/mm3 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: Negative pregnancy test Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since antineoplastic 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: See Disease Characteristics Surgery: Not specified
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: PROTOCOL FOR A PHASE I STUDY OF INTRACYSTIC ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 IN THE TREATMENT OF PATIENTS WITH RECURRENT CYSTIC GLIOMAS
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to determine the effectiveness of monoclonal antibody in treating patients with recurrent gliomas.
Read the detailed description
OBJECTIVES: I. Assess the toxic effects of intracystic administration of iodine-131-labeled anti-tenascin monoclonal antibody 81C6. II. Identify any objective therapeutic responses to this treatment in patients with recurrent cystic anaplastic gliomas.
OUTLINE: Radioimmunotherapy. Iodine-131-Labeled Anti-Tenascin Monoclonal Antibody 81C6, 131I-81C6.
PROJECTED ACCRUAL: Three to six patients will be entered at each dose studied.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- iodine I 131 monoclonal antibody 81C6
- Keywords
- childhood supratentorial ependymoma, recurrent childhood brain tumor, recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult ependymoblastoma, recurrent childhood cerebral astrocytoma, recurrent childhood ependymoma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Glioblastoma, Astrocytoma, Ependymoma, Oligodendroglioma, Glioma, Neuroectodermal Tumors, Primitive
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 posted29 Jul 2004 (estimated)
- Study startNov 1991
- Primary completionApr 2001
- Study completionApr 2001
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
- Primary purpose
- Treatment
- Enrolment
- 6 participants (estimated)
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
- NCT00002753
- Sponsor's protocol ID
- CDR0000064689
- Other IDs
- DUMC-1965-98-12R7, DUMC-1752-96-12R5, DUMC-1775-95-12R4, DUMC-1860-97-12R6, NCI-H96-0008
- Status last verified
- Feb 2013
- First submitted
- 1 Nov 1999
- Last updated
- 18 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTOCOL FOR A PHASE I STUDY OF INTRACYSTIC ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 IN THE TREATMENT OF PATIENTS WITH RECURRENT CYSTIC GLIOMAS
- ClinicalTrials.gov ID
- NCT00002753
- Acronym / sponsor ID
- CDR0000064689
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- childhood supratentorial ependymoma, recurrent childhood brain tumor, recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 1991
- Primary completion
- Apr 2001 (actual)
- Study completion
- Apr 2001 (actual)
- First posted
- 29 Jul 2004 (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: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to determine the effectiveness of monoclonal antibody in treating patients with recurrent gliomas.
Detailed description
OBJECTIVES: I. Assess the toxic effects of intracystic administration of iodine-131-labeled anti-tenascin monoclonal antibody 81C6. II. Identify any objective therapeutic responses to this treatment in patients with recurrent cystic anaplastic gliomas.
OUTLINE: Radioimmunotherapy. Iodine-131-Labeled Anti-Tenascin Monoclonal Antibody 81C6, 131I-81C6.
PROJECTED ACCRUAL: Three to six patients will be entered at each dose studied.
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 18 Feb 2013.
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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 study testing iodine I 131 monoclonal antibody 81C6 in people with Brain and Central Nervous System Tumors, 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 18 Feb 2013. 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 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.
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 18 Feb 2013.