Brain and Central Nervous System TumorsPhase 1NCT00128635
Iodine I 131 Monoclonal Antibody TNT-1/B in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
A Phase 1 study testing iodine I 131 monoclonal antibody TNT-1/B in people with Brain and Central Nervous System Tumors, run by Abramson Cancer Center at Penn Medicine at 4 sites in United States.
Trial summary
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody TNT-1/B (^131I MOAB TNT-1/B), can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for glioblastoma multiforme. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- iodine I 131 monoclonal antibody TNT-1/B
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2005to Oct 2007
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed glioblastoma multiforme
- Focal disease
- Progressive or recurrent disease after prior treatment with radiotherapy and/or chemotherapy
- Low-grade astrocytoma that progressed to glioblastoma multiforme after prior radiotherapy and/or chemotherapy allowed
- Gross tumor volume 5-60 mL
- No intraventricular tumor, infratentorial tumor, or tumor that communicates with the ventricles
- No bilateral non-contiguous gadolinium-enhancing tumor
- No diffuse disease, defined as any satellite lesion > 1.5 cm from the anticipated location of a catheter tip OR > 2 satellite lesions
- No ventricular invasion outside the anticipated radiotherapy volume
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
Hepatic
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Hepatitis B negative
- No evidence of active hepatitis
Renal
- Creatinine ≤ 1.7 mg/dL
- BUN ≤ 2 times ULN
Cardiovascular
- No uncontrolled hypertension
- No unstable angina pectoris
- No uncontrolled cardiac dysrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to undergo MRI
- Mini Mental State Exam score ≥ 15
- No serious infection
- No other medical illness that would preclude study participation
- No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
- No psychological or sociological condition, addictive disorder, or other condition that would preclude study compliance
- No known or suspected allergy to study drug or iodine
- No known HIV positivity
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior monoclonal antibodies
- No prior local immunotherapy or treatment with the following biologic agents:
- Immunotoxins
- Immunoconjugates
- Antiangiogenesis compounds
- Antisense agents
- Peptide receptor antagonist
- Interferons
- Interleukins
- Tumor infiltrating lymphocytes
- Lymphokine-activated killer cells
- Gene therapy
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- At least 3 months since prior polifeprosan 20 with carmustine implant (Gliadel wafer^® )
Endocrine therapy
- Must be maintained on a stable corticosteroid dose (approximately 4 mg) for ≥ 2 weeks before study entry
Radiotherapy
- See Disease Characteristics
- At least 3 months since prior radiotherapy
- No prior brachytherapy or radiosurgery
Surgery
- At least 4 weeks since prior surgery
Other
- Recovered from all prior therapy
- At least 1 month since prior investigational agents
- No more than 2 prior treatment regimens
- No other prior local therapy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham, Alabama, 35294
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: An Open-Label, Dose Confirmation and Dosimetry Study of Interstitial 131 I-chTNT-1/B MAb (COTARA(TM)) For the Treatment of Glioblastoma Multiforme (GBM) at 1st or 2nd Relapse
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody TNT-1/B (^131I MOAB TNT-1/B), can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for glioblastoma multiforme.
PURPOSE: This phase I trial is studying the side effects and best dose of ^131I MOAB TNT-1/B in treating patients with progressive or recurrent glioblastoma multiforme.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of iodine I 131 monoclonal antibody TNT-1/B in patients with progressive or recurrent glioblastoma multiforme.
Secondary
- Determine the biodistribution and radiation dosimetry of this drug in these patients.
- Determine the toxicity and tolerability of this drug in these patients.
- Determine the overall survival, median time of survival, and 6-month survival of patients treated with this drug.
OUTLINE: This is an open-label, multicenter, dose-escalation study of therapeutic doses of iodine I 131 monoclonal antibody TNT-1/B (^131I MOAB TNT-1/B).
The first 12 patients accrued to the study undergo stereotactic placement of 2 catheters within the contrast-enhancing tumor on day 0. These patients then receive an imaging dose of ^131I MOAB TNT-1/B interstitially over approximately 25 hours on day 1 followed by dosimetry, biodistribution evaluations, and whole body imaging over an 8-10 day period. Beginning at least 2 weeks, but no more than 4 weeks later, all patients undergo catheter placement as above. One day later, patients receive a therapeutic dose of ^131I MOAB TNT-1/B interstitially over approximately 25 hours.
Cohorts of 3-6 patients receive escalating therapeutic doses of ^131I MOAB TNT-1/B until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 10 patients are treated at the MTD.
After completion of study treatment, patients are followed weekly for 3 weeks, at 6 weeks, at 4, 8, and 12 weeks (for the first 12 patients accrued to the study), every 4 weeks until disease progression, and then every 8 weeks thereafter.
PROJECTED ACCRUAL: Approximately 22 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- iodine I 131 monoclonal antibody TNT-1/B
- Keywords
- adult glioblastoma, adult gliosarcoma, adult giant cell glioblastoma, recurrent adult brain tumor
- Medical subject headings
- Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iodine I 131 monoclonal antibody TNT-1/BRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose based on CTCAE v3.0 weekly for 8 weeks then every 8 weeks
Secondary outcomes (3)
Biodistribution and radiation dosimetry by blood, urine, and whole body scans daily for 10 days
Toxicity by CTCAE v3.0 weekly for 12 weeks then every 8 weeks
Overall survival, median time of survival, and percent alive at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study startOct 2005
- Study completionOct 2007
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 Abramson Cancer Center at Penn MedicineThe 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
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Robert A. Lustig, MD, Study chair, Abramson Cancer Center at Penn MedicineKevin Judy, MD, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128635
- Sponsor's protocol ID
- CDR0000438768
- Other IDs
- NABTT-0404
- Status last verified
- May 2007
- First submitted
- 8 Aug 2005
- Last updated
- 19 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose Confirmation and Dosimetry Study of Interstitial 131 I-chTNT-1/B MAb (COTARA(TM)) For the Treatment of Glioblastoma Multiforme (GBM) at 1st or 2nd Relapse
- ClinicalTrials.gov ID
- NCT00128635
- Acronym / sponsor ID
- CDR0000438768
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult glioblastoma, adult gliosarcoma, adult giant cell glioblastoma, recurrent adult brain tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2005
- Study completion
- Oct 2007 (actual)
- First posted
- 10 Aug 2005 (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, such as iodine I 131 monoclonal antibody TNT-1/B (^131I MOAB TNT-1/B), can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for glioblastoma multiforme.
PURPOSE: This phase I trial is studying the side effects and best dose of ^131I MOAB TNT-1/B in treating patients with progressive or recurrent glioblastoma multiforme.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of iodine I 131 monoclonal antibody TNT-1/B in patients with progressive or recurrent glioblastoma multiforme.
Secondary
- Determine the biodistribution and radiation dosimetry of this drug in these patients.
- Determine the toxicity and tolerability of this drug in these patients.
- Determine the overall survival, median time of survival, and 6-month survival of patients treated with this drug.
OUTLINE: This is an open-label, multicenter, dose-escalation study of therapeutic doses of iodine I 131 monoclonal antibody TNT-1/B (^131I MOAB TNT-1/B).
The first 12 patients accrued to the study undergo stereotactic placement of 2 catheters within the contrast-enhancing tumor on day 0. These patients then receive an imaging dose of ^131I MOAB TNT-1/B interstitially over approximately 25 hours on day 1 followed by dosimetry, biodistribution evaluations, and whole body imaging over an 8-10 day period. Beginning at least 2 weeks, but no more than 4 weeks later, all patients undergo catheter placement as above. One day later, patients receive a therapeutic dose of ^131I MOAB TNT-1/B interstitially over approximately 25 hours.
Cohorts of 3-6 patients receive escalating therapeutic doses of ^131I MOAB TNT-1/B until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 10 patients are treated at the MTD.
After completion of study treatment, patients are followed weekly for 3 weeks, at 6 weeks, at 4, 8, and 12 weeks (for the first 12 patients accrued to the study), every 4 weeks until disease progression, and then every 8 weeks thereafter.
PROJECTED ACCRUAL: Approximately 22 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| iodine I 131 monoclonal antibody TNT-1/B | Radiation | – |
Primary outcome
Maximum tolerated dose based on CTCAE v3.0 weekly for 8 weeks then every 8 weeks
3 secondary outcomes
Biodistribution and radiation dosimetry by blood, urine, and whole body scans daily for 10 days
Toxicity by CTCAE v3.0 weekly for 12 weeks then every 8 weeks
Overall survival, median time of survival, and percent alive at 6 months
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 19 Feb 2016.
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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.
Robert A. Lustig, MD study chair
Abramson Cancer Center at Penn Medicine
Kevin Judy, MD
Abramson Cancer Center at Penn Medicine
4 sites 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 TNT-1/B in people with Brain and Central Nervous System Tumors, run by Abramson Cancer Center at Penn Medicine at 4 sites 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 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does the primary outcome measure?
Maximum tolerated dose based on CTCAE v3.0 weekly for 8 weeks then every 8 weeks. It is what the study was designed to measure, not a finding.
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 19 Feb 2016.