Brain CancerPhase 1NCT01058850
Phase I Rindopepimut After Conventional Radiation in Children w/ Diffuse Intrinsic Pontine Gliomas
A Phase 1 study testing Rindopepimut in people with Brain Cancer and Brain Stem Tumors, run by Paul Graham Fisher at 1 site in United States.
Trial summary
This is a research study of patients with diffuse intrinsic pontine gliomas. We hope to learn about the safety and efficacy of treating pediatric diffuse intrinsic pontine glioma patients with the EGFRvIII peptide vaccine after conventional radiation. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Brain Cancer, Brain Stem Tumors, Pontine Tumors
- What is being tested?
- Rindopepimut
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Sep 2013
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 3.1.1 Patients must be at least 3 years of age and ≤ 18 years of age at the time of study enrollment.
- 3.1.2 Patients must have clinical findings and neuroradiographic findings consistent with diffuse intrinsic pontine glioma. Histologic confirmation of diagnosis is not required for diffuse intrinsic pontine gliomas. A copy of the MRI must be submitted for verification of eligibility.
- 3.1.3 Patients must have received conventional radiation therapy of total radiation dosage ranging from 5400 to 6000 cGy administered in fractions of 150 to 200 cGy over 6 weeks.
- 3.1.4 Treatment must start 14 to 28 days after completion of conventional radiation
- 3.1.5 Patients receiving systemic corticosteroid therapy must be on a tapering or stable low (2 mg twice daily) dose of dexamethasone two weeks after conventional radiation.
- 3.1.6 Patients life expectancy must be greater or equal to 8 weeks.
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- 3.1.7 Patients must have a performance status (Lansky or Karnofsky) ≥ 50.
- 3.1.8 Platelet count ≥ 100,000/ mm3.
- 3.1.9 Hemoglobin ≥ 10 g/dL.
- 3.1.10 Creatinine ≤ 2.0 mg/dL.
- 3.1.11 Serum bilirubin ≤ 5.0 mg/dL.
- 3.1.12 If female, patients of childbearing potential must have a negative serum β-hCG pregnancy test.
- 3.1.13 Both male and female patients must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study.
- 3.1.14 The patient and/or their guardian must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 3.2.1 Prior therapy for diffuse intrinsic pontine glioma, aside from surgery, conventional radiation, and temozolomide.
- 3.2.2 Use of any experimental drug for any reason within the 60 days prior to treatment.
- 3.2.3 Active infection requiring treatment.
- 3.2.4 Known medical condition that, in the opinion of the Investigator, would compromise the patient's ability to participate in the study. This would include chronic active hepatitis infection, known immunosuppressive disease or concurrent neurodegenerative disease.
- 3.2.5 Known allergy or hypersensitivity to any of the components of the vaccine treatment, including GM-CSF, yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
- 3.2.6 Pregnant women and women who are breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase I Study of Rindopepimut After Conventional Radiation in Children With Diffuse Intrinsic Pontine Gliomas
This is a research study of patients with diffuse intrinsic pontine gliomas. We hope to learn about the safety and efficacy of treating pediatric diffuse intrinsic pontine glioma patients with the EGFRvIII peptide vaccine after conventional radiation.
- Conditions
- Brain Cancer, Brain Stem Tumors, Pontine Tumors
- Being tested
- Rindopepimut
- Medical subject headings
- Brain Neoplasms, Brain Stem Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RindopepimutBiological
Also called CDX-110, EGFRvIII peptide vaccine
250 or 500 mcg; intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| Rindopepimut (EGFRvIII Vaccine, CDX-110) | Experimental | Not described Receives: Biological: Rindopepimut |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: Monthly until death or until 5years
Secondary outcomes (1)
Overall survival
Measured: Monthly until death or until 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startJun 2011
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Resources can be better spent on higher enrolling studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Graham Fisher
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Paul Graham Fisher, Stanford University
- Investigators
- Paul Graham Fisher, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058850
- Sponsor's protocol ID
- PEDSBRN0008
- Other IDs
- SU-01062010-4642, 1RC2CA148491-01
- Status last verified
- Sep 2021
- First submitted
- 27 Jan 2010
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Rindopepimut After Conventional Radiation in Children With Diffuse Intrinsic Pontine Gliomas
- ClinicalTrials.gov ID
- NCT01058850
- Acronym / sponsor ID
- PEDSBRN0008
- Conditions
- Brain Cancer, Brain Stem Tumors, Pontine Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resources can be better spent on higher enrolling studies
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Paul Graham FisherUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Jun 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 29 Jan 2010 (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 research study of patients with diffuse intrinsic pontine gliomas. We hope to learn about the safety and efficacy of treating pediatric diffuse intrinsic pontine glioma patients with the EGFRvIII peptide vaccine after conventional radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rindopepimut (EGFRvIII Vaccine, CDX-110) | Experimental | Biological: Rindopepimut |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 3.1.1 Patients must be at least 3 years of age and ≤ 18 years of age at the time of study enrollment.
- 3.1.2 Patients must have clinical findings and neuroradiographic findings consistent with diffuse intrinsic pontine glioma. Histologic confirmation of diagnosis is not required for diffuse intrinsic pontine gliomas. A copy of the MRI must be submitted for verification of eligibility.
- 3.1.3 Patients must have received conventional radiation therapy of total radiation dosage ranging from 5400 to 6000 cGy administered in fractions of 150 to 200 cGy over 6 weeks.
- 3.1.4 Treatment must start 14 to 28 days after completion of conventional radiation
- 3.1.5 Patients receiving systemic corticosteroid therapy must be on a tapering or stable low (2 mg twice daily) dose of dexamethasone two weeks after conventional radiation.
Key exclusion criteria (6 listed)
- 3.2.1 Prior therapy for diffuse intrinsic pontine glioma, aside from surgery, conventional radiation, and temozolomide.
- 3.2.2 Use of any experimental drug for any reason within the 60 days prior to treatment.
- 3.2.3 Active infection requiring treatment.
- 3.2.4 Known medical condition that, in the opinion of the Investigator, would compromise the patient's ability to participate in the study. This would include chronic active hepatitis infection, known immunosuppressive disease or concurrent neurodegenerative disease.
- 3.2.5 Known allergy or hypersensitivity to any of the components of the vaccine treatment, including GM-CSF, yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
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 |
|---|---|---|
| RindopepimutAlso: CDX-110, EGFRvIII peptide vaccine250 or 500 mcg; intradermal injection | Biological | Rindopepimut (EGFRvIII Vaccine, CDX-110) |
Primary outcome
Safety
Time frame: Monthly until death or until 5years
1 secondary outcome
Overall survival
Time frame: Monthly until death or until 5years
Results and safety
The study was stopped early (reason given: Resources can be better spent on higher enrolling studies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
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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.
Paul Graham Fisher principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rindopepimut in people with Brain Cancer and Brain Stem Tumors, run by Paul Graham Fisher at 1 site 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 14 inclusion and 6 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: stopped early, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Resources can be better spent on higher enrolling studies). Results are not available in the source record.
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?
Safety (time frame: Monthly until death or until 5years). 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 27 Sep 2021.