Recurrent Glioblastoma MultiformePhase 1NCT00509301
Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme
A Phase 1 study testing 131-I-chTNT-1/B MAB in people with Recurrent Glioblastoma Multiforme, run by Peregrine Pharmaceuticals at 4 sites in United States.
Trial summary
RATIONALE: Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma Multiforme
- What is being tested?
- 131-I-chTNT-1/B MAB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2006to 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
Who may be able to join
- Patients with recurrent GBM
- Patients with a Clinical Target Volume between 5 and 60 cc (inclusive)
- Patients of 18 years of age or older
- Karnofsky Performance Status ≥ 60 at screening
- Patients not on steroids or maintained on a stable corticosteroid regimen (± 4 mg) for at least 2 weeks prior to study entry
Who cannot join
- Patients with infratentorial tumor(s), exophytic intra-ventricular tumor(s) or subependymal tumor spread extending greater than 2 cm
- Patients with diffuse disease
- Patients with known or suspected allergy to study medication or iodine
- Patients who received investigational agents within 30 days prior to baseline
- Patients who received surgical resection within 4 weeks from baseline
- Patients with known HIV or evidence of active hepatitis
- Patients who cannot undergo MRI
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Barrow Neurological Institute
Phoenix, Arizona, 85013
About this study
Official title: Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme
RATIONALE: Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out." This may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer.
PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients with recurrent glioblastoma multiforme.
Read the detailed description
OBJECTIVES:
Primary
- To confirm the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of 131I-chTNT-1/B MAb (Cotara®) when given as a single 25 hour interstitial infusion in patients with recurrent GBM
- To characterize the biodistribution and radiation dosimetry of Cotara®
OUTLINE:
This is an open-label, dose escalation study of Cotara®.
All patients will receive 3 mCi of Cotara® for biodistribution and radiation dosimetry purposes. In addition, patients will receive escalating therapeutic dose levels of Cotara® for confirmation of the maximum tolerated dose (MTD). After completion of study treatment, patients are followed for a minimum of 12 weeks and until disease progression.
- Conditions
- Recurrent Glioblastoma Multiforme
- Being tested
- 131-I-chTNT-1/B MAB
- Keywords
- brain cancer, Cotara, radioactive isotope, monoclonal antibody, radiation distribution
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131-I-chTNT-1/B MABDrug
Also called Cotara
The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1.5 mCi/cc Receives: Drug: 131-I-chTNT-1/B MAB |
| 2 | Experimental | 2.0 mCi/cc Receives: Drug: 131-I-chTNT-1/B MAB |
| 3 | Experimental | 2.5 mCi/cc Receives: Drug: 131-I-chTNT-1/B MAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm dose limit and maximum tolerated dose and to characterize radiation distribution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startNov 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Glioblastoma MultiformeStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peregrine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sunil J Patel, MD, Principal investigator, Medical University of South CarolinaKenneth M Spicer, MD PhD, Principal investigator, Medical University of South CarolinaKevin D Judy, MD, Principal investigator, University of PennsylvaniaWilliam R Shapiro, MD, Principal investigator, Barrow Neurological InstituteAndrew E Sloan, MD, FACS, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509301
- Sponsor's protocol ID
- PPHM 0602
- Status last verified
- Aug 2011
- First submitted
- 27 Jul 2007
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00509301
- Acronym / sponsor ID
- PPHM 0602
- Conditions
- Recurrent Glioblastoma Multiforme
- Keywords
- brain cancer, Cotara, radioactive isotope, monoclonal antibody, radiation distribution
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Peregrine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 31 Jul 2007 (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: Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out." This may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer.
PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients with recurrent glioblastoma multiforme.
Detailed description
OBJECTIVES:
Primary
- To confirm the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of 131I-chTNT-1/B MAb (Cotara®) when given as a single 25 hour interstitial infusion in patients with recurrent GBM
- To characterize the biodistribution and radiation dosimetry of Cotara®
OUTLINE:
This is an open-label, dose escalation study of Cotara®.
All patients will receive 3 mCi of Cotara® for biodistribution and radiation dosimetry purposes. In addition, patients will receive escalating therapeutic dose levels of Cotara® for confirmation of the maximum tolerated dose (MTD). After completion of study treatment, patients are followed for a minimum of 12 weeks and until disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 131-I-chTNT-1/B MAB1.5 mCi/cc |
| 2 | Experimental | Drug: 131-I-chTNT-1/B MAB2.0 mCi/cc |
| 3 | Experimental | Drug: 131-I-chTNT-1/B MAB2.5 mCi/cc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with recurrent GBM
- Patients with a Clinical Target Volume between 5 and 60 cc (inclusive)
- Patients of 18 years of age or older
- Karnofsky Performance Status ≥ 60 at screening
- Patients not on steroids or maintained on a stable corticosteroid regimen (± 4 mg) for at least 2 weeks prior to study entry
Key exclusion criteria (7 listed)
- Patients with infratentorial tumor(s), exophytic intra-ventricular tumor(s) or subependymal tumor spread extending greater than 2 cm
- Patients with diffuse disease
- Patients with known or suspected allergy to study medication or iodine
- Patients who received investigational agents within 30 days prior to baseline
- Patients who received surgical resection within 4 weeks from baseline
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 |
|---|---|---|
| 131-I-chTNT-1/B MABAlso: CotaraThe study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc. | Drug | 1, 2, 3 |
Primary outcome
To confirm dose limit and maximum tolerated dose and to characterize radiation distribution
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 5 Aug 2011.
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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.
Sunil J Patel, MD principal investigator
Medical University of South Carolina
Kenneth M Spicer, MD PhD principal investigator
Medical University of South Carolina
Kevin D Judy, MD principal investigator
University of Pennsylvania
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 131-I-chTNT-1/B MAB in people with Recurrent Glioblastoma Multiforme, run by Peregrine Pharmaceuticals 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?
The sponsor lists 5 inclusion and 7 exclusion criteria. 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 5 Aug 2011. 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?
To confirm dose limit and maximum tolerated dose and to characterize radiation distribution. 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 5 Aug 2011.