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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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.

  1. Maximum tolerated dose based on CTCAE v3.0 weekly for 8 weeks then every 8 weeks

Secondary outcomes (3)
  1. Biodistribution and radiation dosimetry by blood, urine, and whole body scans daily for 10 days

  2. Toxicity by CTCAE v3.0 weekly for 12 weeks then every 8 weeks

  3. 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.

  1. First posted10 Aug 2005 (estimated)
  2. Study startOct 2005
  3. Study completionOct 2007

Resources

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)
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

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.

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