Brain and Central Nervous System TumorsPhase 1NCT00003484
Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors
A Phase 1 study testing carmustine, irinotecan hydrochloride and surgical procedure in people with Brain and Central Nervous System Tumors and Neuroblastoma, run by Darell D. Bigner, MD, PhD at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Neuroblastoma
- What is being tested?
- carmustine, irinotecan hydrochloride and surgical procedure
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1997to Mar 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 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 I-Labeled 81C6 Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary Brain Tumors After External Beam Radiotherapy
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.
Read the 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.
- Being tested
- carmustine, irinotecan hydrochloride, surgical procedure, iodine I 131 monoclonal antibody 81C6
- Keywords
- localized resectable neuroblastoma, recurrent adult brain tumor, adult craniopharyngioma, adult medulloblastoma, adult meningioma, adult glioblastoma, adult oligodendroglioma, adult anaplastic astrocytoma, adult mixed glioma, adult pineal parenchymal tumor, adult central nervous system germ cell tumor, adult grade III meningioma, adult pilocytic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Neuroblastoma, Brain Neoplasms, Craniopharyngioma, Medulloblastoma, Meningioma, Glioblastoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carmustineDrug
surgical procedureProcedure or surgery
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 posted30 Apr 2003 (estimated)
- Study startSep 1997
- Primary completionNov 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.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Darell D. Bigner, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Darell D. Bigner, MD, PhD, Duke University
- Investigators
- Darell D. Bigner, MD, PhD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003484
- Sponsor's protocol ID
- Pro00008915
- Other IDs
- 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, 5P0NS20023
- Status last verified
- Apr 2015
- First submitted
- 1 Nov 1999
- Last updated
- 23 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00003484
- Acronym / sponsor ID
- Pro00008915
- Keywords
- localized resectable neuroblastoma, recurrent adult brain tumor, adult craniopharyngioma, adult medulloblastoma, adult meningioma, adult glioblastoma, adult oligodendroglioma, adult anaplastic astrocytoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Darell D. Bigner, MD, PhDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 1997
- Primary completion
- Nov 2003 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 Apr 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: 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| carmustine | Drug | – |
| irinotecan hydrochloride | Drug | – |
| surgical procedure | Procedure or surgery | – |
| 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 23 Apr 2015.
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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 University
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 carmustine, irinotecan hydrochloride and surgical procedure in people with Brain and Central Nervous System Tumors and Neuroblastoma, run by Darell D. Bigner, MD, PhD 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 23 Apr 2015. 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 23 Apr 2015.