Glioblastoma MultiformePhase 2NCT00677716
Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse
A Phase 2 study testing 131I-chTNT-1/B MAb (Cotara) in people with Glioblastoma Multiforme, run by Peregrine Pharmaceuticals at 7 sites in 2 countries.
Trial summary
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 to 75 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- 131I-chTNT-1/B MAb (Cotara)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jul 2007to Nov 2011
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed GBM
- Clinical Target Volume between 5 and 60 cc (inclusive)
- 18 to 75 years old (inclusive)
- Karnofsky Performance Status ≥ 70 percent
- If on steroids dose (± 4mg/day) must be stable for at least two weeks prior to screening/baseline visit. If not on steroids for two weeks prior to screening/baseline visit are allowed
- Adequate hematology
- Adequate renal function
- Adequate liver function
Who cannot join
- Infratentorial tumor(s), tumor(s) that communicate with the ventricles or intraventricular disease
- Bilateral non-contiguous gadolinium enhancing tumor
- Diffuse disease (i.e., any satellite lesions less than 1.5 cm from anticipated location of any catheter tip or less than two satellite lesions)
- Known or suspected allergy to study medication or iodine
- Surgical procedure within four weeks of baseline
- More than one prior chemotherapy regime or chemotherapy within four weeks (nitrosourea-based within six weeks) of baseline
Show all 11Show fewer
- Radiation therapy within four weeks of baseline
- Investigational agent within last 30 days
- Previous treatment with any chimeric monoclonal antibody
- HIV positive
- Evidence of active hepatitis
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
India4 sites
Manipal Institute for Neurological Disorders,
Bangalore, 560 017
Amrita Institute of Medical Sciences and Research Center,
Kochi, Kerala, 682026
Department of Neurosurgery Jaslok Hospital and Research Centre
Mumbai
All India Instutite of Medical Sciences
New Delhi, 110029
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Pennsylvania, Department of Neurosurgery
Philadelphia, Pennsylvania, 19104
Barrow Neurological Institute
Phoenix, Arizona, 85013
About this study
Official title: Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse
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.
Read the detailed description
To confirm the safety and tolerability of the Maximum Tolerated Dose (MTD) of 131I-chTNT-1/B MAb given as a single interstitial infusion in patients with glioblastoma multiforme at first relapse.
To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.
- Conditions
- Glioblastoma Multiforme
- Being tested
- 131I-chTNT-1/B MAb (Cotara)
- Keywords
- glioblastoma multiforme, GBM, brain cancer, Cotara, radioactive isotope, monoclonal antibody, Glioblastoma multiforme at first relapse
- 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.
131I-chTNT-1/B MAb (Cotara)Drug
Also called Cotara®
Given as a single interstitial infusion over approximately 25 hours at a dose of 2.5 mCi/cc.
| Study group | Role | What they receive |
|---|---|---|
| 131I-chTNT-1/B MAb (Cotara) | Experimental | Not described Receives: Drug: 131I-chTNT-1/B MAb (Cotara) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm the safety and tolerability of the maximum tolerated dose
Secondary outcomes (1)
To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startJul 2007
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peregrine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deepak K Gupta, MBBS,MS,MCh, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677716
- Sponsor's protocol ID
- PPHM 0503
- Status last verified
- Apr 2014
- First submitted
- 12 May 2008
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse
- ClinicalTrials.gov ID
- NCT00677716
- Acronym / sponsor ID
- PPHM 0503
- Conditions
- Glioblastoma Multiforme
- Keywords
- glioblastoma multiforme, GBM, brain cancer, Cotara, radioactive isotope, monoclonal antibody, Glioblastoma multiforme at first relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Peregrine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 May 2008 (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.
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.
Detailed description
To confirm the safety and tolerability of the Maximum Tolerated Dose (MTD) of 131I-chTNT-1/B MAb given as a single interstitial infusion in patients with glioblastoma multiforme at first relapse.
To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 131I-chTNT-1/B MAb (Cotara) | Experimental | Drug: 131I-chTNT-1/B MAb (Cotara) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed GBM
- Clinical Target Volume between 5 and 60 cc (inclusive)
- 18 to 75 years old (inclusive)
- Karnofsky Performance Status ≥ 70 percent
- If on steroids dose (± 4mg/day) must be stable for at least two weeks prior to screening/baseline visit. If not on steroids for two weeks prior to screening/baseline visit are allowed
Key exclusion criteria (11 listed)
- Infratentorial tumor(s), tumor(s) that communicate with the ventricles or intraventricular disease
- Bilateral non-contiguous gadolinium enhancing tumor
- Diffuse disease (i.e., any satellite lesions less than 1.5 cm from anticipated location of any catheter tip or less than two satellite lesions)
- Known or suspected allergy to study medication or iodine
- Surgical procedure within four weeks of 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 |
|---|---|---|
| 131I-chTNT-1/B MAb (Cotara)Also: Cotara®Given as a single interstitial infusion over approximately 25 hours at a dose of 2.5 mCi/cc. | Drug | 131I-chTNT-1/B MAb (Cotara) |
Primary outcome
To confirm the safety and tolerability of the maximum tolerated dose
1 secondary outcome
To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.
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 24 Apr 2014.
Related trials for Glioblastoma Multiforme
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
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.
Deepak K Gupta, MBBS,MS,MCh principal investigator
All India Institute of Medical Sciences
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 131I-chTNT-1/B MAb (Cotara) in people with Glioblastoma Multiforme, run by Peregrine Pharmaceuticals at 7 sites in 2 countries.
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 8 inclusion and 11 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 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 the safety and tolerability of the maximum tolerated dose. 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 24 Apr 2014.