Recurrent Diffuse Pontine GliomasPhase 2NCT00600054
Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma
A Phase 2 study testing nimotuzumab (anti EGFR humanized monoclonal antibody) in people with Recurrent Diffuse Pontine Gliomas, run by YM BioSciences at 13 sites in 3 countries.
Trial summary
This is a phase 2, single-arm, multi-center study, with a safety review component, designed to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with recurrent diffuse intrinsic pontine glioma (DIPG) following one previous regimen for their disease. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Recurrent Diffuse Pontine Gliomas
- What is being tested?
- nimotuzumab (anti EGFR humanized monoclonal antibody)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Oct 2007to Dec 2010
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed written informed consent
- Patients with recurrent, diffuse intrinsic pontine gliomas
- Patients should have had 2 of the following 3 neurological symptoms: cranial nerve deficit, long tract signs, ataxia and a onset prior to initial diagnosis < 6 months.
- Evidence of disease progression
- Have a Lansky or Karnofsky Performance Status of > 40
- Be between the age >3 years to < 18 years of age
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- Have a tumor that is measurable radiologically
- For female patients of childbearing age: presence of a negative pregnancy test within 7 days prior to day 0.
- Use of effective contraception
- Adequate hematological, renal, and hepatic function
Who cannot join
- A history of prior use of EGFR-targeting agents (monoclonal antibodies, tyrosine kinase inhibitors)
- More than one line of treatment
- Patients with disseminated disease are not eligible
- Had radiation therapy completed within 12 weeks of enrollment
- Previous chemotherapy completed < 2 weeks prior to enrollment
- If female, is pregnant or lactating
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- Has other existing serious medical conditions
- Has any condition, therapy, or medical condition, which, in the opinion of the attending physician could represent a risk for the patient or adversely affect the study objectives
- Is currently taking or planning to take other investigational drugs during the study
- Known contraindications against antibodies
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States10 sites
The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins
Baltimore, Maryland, 21287
Children's Memorial Hospital
Chicago, Illinois, 60614-3394
Children's Hospital/University of Colorado
Denver, Colorado, 80045
University of Florida Shands Cancer Center
Gainesville, Florida, 32611
The University of Texas/M.D. Anderson Cancer Center
Houston, Texas, 77030
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6310
NYU Medical Center, Hassenfeld Clinic
New York, New York, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
University of Rochester Medical Center, Strong Memorial Hospital
Rochester, New York, 10016
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Canada2 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
The Hospital For Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: Phase 2 Study of Safety and Efficacy of Nimotuzumab (TheraCIM®) in Pediatric Patients With Recurrent Diffuse Intrinsic Pontine Glioma
This is a phase 2, single-arm, multi-center study, with a safety review component, designed to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with recurrent diffuse intrinsic pontine glioma (DIPG) following one previous regimen for their disease. Patients must be diagnosed with radiologically verified recurrent diffuse intrinsic pontine glioma that is measurable in at least two dimensions. Patients are eligible without histologic confirmation. Treatment regimen will consist of two phases-induction and consolidation.
- Conditions
- Recurrent Diffuse Pontine Gliomas
- Being tested
- nimotuzumab (anti EGFR humanized monoclonal antibody)
- Keywords
- Diffuse intrinsic pontine glioma, Common Terminology Criteria, Epidermal Growth factor receptor, Human antihuman antibody, pharmacokinetics, monoclonal antibody, Informed Consent Form
- Medical subject headings
- Diffuse Intrinsic Pontine Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nimotuzumab (anti EGFR humanized monoclonal antibody)Biological
150 mg/m2 I.V. Induction phase: infusions once a week for 8 weeks. Consolidation phase: infusions once every 2 weeks for 10 weeks. Patients may then continue on the consolidation regimen of nimotuzumab, until disease progression or the occurrence of unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Biological: nimotuzumab (anti EGFR humanized monoclonal antibody) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the objective response rate
Measured: To determine response rate on week 18
Secondary outcomes (1)
To evaluate the safety profile of single agent nimotuzumab in this population
Measured: safety will be evaluated after each study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Diffuse Pontine GliomasStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- YM BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Bouffet, MD, Principal investigator, The Hospital for Sick ChildrenUte Bartels, MD, Principal investigator, The Hospital for Sick ChildrenSylvain Baruchel, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600054
- Sponsor's protocol ID
- YMB1000-013
- Status last verified
- Jul 2011
- First submitted
- 11 Jan 2008
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Safety and Efficacy of Nimotuzumab (TheraCIM®) in Pediatric Patients With Recurrent Diffuse Intrinsic Pontine Glioma
- ClinicalTrials.gov ID
- NCT00600054
- Acronym / sponsor ID
- YMB1000-013
- Conditions
- Recurrent Diffuse Pontine Gliomas
- Keywords
- Diffuse intrinsic pontine glioma, Common Terminology Criteria, Epidermal Growth factor receptor, Human antihuman antibody, pharmacokinetics, monoclonal antibody, Informed Consent Form
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- YM BioSciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 24 Jan 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.
This is a phase 2, single-arm, multi-center study, with a safety review component, designed to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with recurrent diffuse intrinsic pontine glioma (DIPG) following one previous regimen for their disease. Patients must be diagnosed with radiologically verified recurrent diffuse intrinsic pontine glioma that is measurable in at least two dimensions. Patients are eligible without histologic confirmation. Treatment regimen will consist of two phases-induction and consolidation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Biological: nimotuzumab (anti EGFR humanized monoclonal antibody) |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Signed written informed consent
- Patients with recurrent, diffuse intrinsic pontine gliomas
- Patients should have had 2 of the following 3 neurological symptoms: cranial nerve deficit, long tract signs, ataxia and a onset prior to initial diagnosis < 6 months.
- Evidence of disease progression
- Have a Lansky or Karnofsky Performance Status of > 40
Key exclusion criteria (10 listed)
- A history of prior use of EGFR-targeting agents (monoclonal antibodies, tyrosine kinase inhibitors)
- More than one line of treatment
- Patients with disseminated disease are not eligible
- Had radiation therapy completed within 12 weeks of enrollment
- Previous chemotherapy completed < 2 weeks prior to enrollment
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 |
|---|---|---|
| nimotuzumab (anti EGFR humanized monoclonal antibody)150 mg/m2 I.V. Induction phase: infusions once a week for 8 weeks. Consolidation phase: infusions once every 2 weeks for 10 weeks. Patients may then continue on the consolidation regimen of nimotuzumab, until disease progression or the occurrence of unacceptable toxicity. | Biological | Single arm |
Primary outcome
To determine the objective response rate
Time frame: To determine response rate on week 18
1 secondary outcome
To evaluate the safety profile of single agent nimotuzumab in this population
Time frame: safety will be evaluated after each study drug administration
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 6 Jul 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.
Eric Bouffet, MD principal investigator
The Hospital for Sick Children
Ute Bartels, MD principal investigator
The Hospital for Sick Children
Sylvain Baruchel, MD principal investigator
The Hospital for Sick Children
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nimotuzumab (anti EGFR humanized monoclonal antibody) in people with Recurrent Diffuse Pontine Gliomas, run by YM BioSciences at 13 sites in 3 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 10 inclusion and 10 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 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada, Israel. 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 determine the objective response rate (time frame: To determine response rate on week 18). 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 6 Jul 2011.