Tumors, Central Nervous SystemPhase 1NCT00935545
Study of Peptide Vaccination With Tumor Associated Antigens Mixed With Montanide in Patients With CNS Tumors
A Phase 1 study testing Montanide in people with Tumors, Central Nervous System, run by NYU Langone Health at 1 site in United States.
Trial summary
This is an open-label, single arm study evaluating a multi-peptide (tumor-associated antigens)/Montanide vaccine in patients < 21 years of age with recurrent or refractory CNS tumors. The study primarily evaluates the safety of this regimen. Secondarily, immunogenicity and anti-tumor effects will be assessed. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Tumors, Central Nervous System
- What is being tested?
- Montanide
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jan 2014
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with primary central nervous system tumors recurrent or refractory to standard therapy. Patients with recurrent tumors other than refractory anaplastic astrocytoma, glioblastoma multiforme or medulloblastoma must have failed all available second line therapies considered to be standard of care prior to inclusion in this study.
- Patients with tumor histologies which have previously been shown to express at least one of the tumor associated antigens (TRP2, gp100, EphA2 or Her2) are eligible. Patients whose tumors are shown to express at least one of these antigens are also eligible.
- Patients must be HLA A*0201 positive.
- Age < 21 years
- Patients must weigh > 15kg due to the amount of blood required for immune function studies.
- Lansky performance status or Karnofsky performance status > 50. Patients who are unable to walk because of paralysis but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
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- Adequate organ function:
- Hematologic: WBC > 1000/mm3 Absolute lymphocyte count > 500 Hemoglobin > 9 gm/dl (may be transfused to achieve adequate hemoglobin level) Platelet count > 50,000/mm3 INR and PTT < 1.5 x the upper limit of normal
- Hepatic: AST/ALT < 2 x the upper limit of institutional normal Total bilirubin < 1.5 x the upper limit of institutional normal
- Renal: Serum creatinine < upper limit of normal for the patient's age
- Life expectancy > 3 months
- Patients must have fully recovered from previous surgery, chemotherapy, radiotherapy and biologic therapy. No chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to the first dose of study agent (6 weeks for nitrosureas)
- Measurable disease is not required.
- Informed consent must be signed by the patient or legal representative.
Who cannot join
- Serious illness, eg, uncontrolled infections requiring antibiotics.
- History of immunodeficiency disease (such as HIV) or autoimmune disease except vitiligo.
- Concomitant treatment with systemic corticosteroids greater than physiologic doses. Topical (but not at the proposed vaccination site) or inhalational steroids are permitted.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior the first dose of study agent.
- Pregnant or lactating women are not permitted.
- Women of child-bearing potential not using medically acceptable means of contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
Official title: A Phase I Study of Peptide Vaccination With Tumor Associated Antigens Mixed With Montanide ISA-51VG in Pediatric Patients With Recurrent or Refractory Central Nervous System Tumors
This is an open-label, single arm study evaluating a multi-peptide (tumor-associated antigens)/Montanide vaccine in patients < 21 years of age with recurrent or refractory CNS tumors. The study primarily evaluates the safety of this regimen. Secondarily, immunogenicity and anti-tumor effects will be assessed.
The primary aim is to evaluate the safety of subcutaneous injections of tumor associated antigens (TAA) mixed with Montanide ISA-51VG in patients with recurrent or refractory brain tumors.
The secondary aims are to evaluate cellular immune responses induced in patients after subcutaneous injection of TAA mixed with Montanide ISA-51VG and to document tumor response in patients with measurable disease or time to progression in patients without measurable disease following subcutaneous injection of TAA mixed with Montanide ISA-51VG.
- Conditions
- Tumors, Central Nervous System
- Being tested
- Montanide
- Keywords
- Brain Tumors, High Grade, CNS
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontanideBiological
Also called Montanide ISA-51 VG
Montanide is an oil-based immunoadjuvant similar to Incomplete Freund´s Adjuvant, which is commonly used in combination with peptide vaccines. Although its precise mode of action is not known, it acts to enhance the immune response to vaccination. It has a depot effect that depending on the type of emulsion will release the antigen slowly from the injection site.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Not described Receives: Biological: Montanide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim is to evaluate the safety of subcutaneous injections of tumor associated antigens (TAA) mixed with Montanide ISA-51VG in patients with recurrent or refractory brain tumors.
Measured: 2-4 weeks
Secondary outcomes (1)
Evaluate cellular immune responses induced in pts after injection of TAA mixed with Montanide and document tumor response in pts w/ measurable disease or time to progression in pts without measurable disease following injection of TAA mixed w/ Montanide.
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumors, Central Nervous SystemStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon Gardner, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935545
- Sponsor's protocol ID
- 08-1017
- Status last verified
- Jan 2016
- First submitted
- 7 Jul 2009
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Peptide Vaccination With Tumor Associated Antigens Mixed With Montanide ISA-51VG in Pediatric Patients With Recurrent or Refractory Central Nervous System Tumors
- ClinicalTrials.gov ID
- NCT00935545
- Acronym / sponsor ID
- 08-1017
- Conditions
- Tumors, Central Nervous System
- Keywords
- Brain Tumors, High Grade, CNS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 9 Jul 2009 (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 an open-label, single arm study evaluating a multi-peptide (tumor-associated antigens)/Montanide vaccine in patients < 21 years of age with recurrent or refractory CNS tumors. The study primarily evaluates the safety of this regimen. Secondarily, immunogenicity and anti-tumor effects will be assessed.
The primary aim is to evaluate the safety of subcutaneous injections of tumor associated antigens (TAA) mixed with Montanide ISA-51VG in patients with recurrent or refractory brain tumors.
The secondary aims are to evaluate cellular immune responses induced in patients after subcutaneous injection of TAA mixed with Montanide ISA-51VG and to document tumor response in patients with measurable disease or time to progression in patients without measurable disease following subcutaneous injection of TAA mixed with Montanide ISA-51VG.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Biological: Montanide |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Patients with primary central nervous system tumors recurrent or refractory to standard therapy. Patients with recurrent tumors other than refractory anaplastic astrocytoma, glioblastoma multiforme or medulloblastoma must have failed all available second line therapies considered to be standard of care prior to inclusion in this study.
- Patients with tumor histologies which have previously been shown to express at least one of the tumor associated antigens (TRP2, gp100, EphA2 or Her2) are eligible. Patients whose tumors are shown to express at least one of these antigens are also eligible.
- Patients must be HLA A*0201 positive.
- Age < 21 years
- Patients must weigh > 15kg due to the amount of blood required for immune function studies.
Key exclusion criteria (6 listed)
- Serious illness, eg, uncontrolled infections requiring antibiotics.
- History of immunodeficiency disease (such as HIV) or autoimmune disease except vitiligo.
- Concomitant treatment with systemic corticosteroids greater than physiologic doses. Topical (but not at the proposed vaccination site) or inhalational steroids are permitted.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior the first dose of study agent.
- Pregnant or lactating women are not permitted.
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 |
|---|---|---|
| MontanideAlso: Montanide ISA-51 VGMontanide is an oil-based immunoadjuvant similar to Incomplete Freund´s Adjuvant, which is commonly used in combination with peptide vaccines. Although its precise mode of action is not known, it acts to enhance the immune response to vaccination. It has a depot effect that depending on the type of emulsion will release the antigen slowly from the injection site. | Biological | Open Label |
Primary outcome
The primary aim is to evaluate the safety of subcutaneous injections of tumor associated antigens (TAA) mixed with Montanide ISA-51VG in patients with recurrent or refractory brain tumors.
Time frame: 2-4 weeks
1 secondary outcome
Evaluate cellular immune responses induced in pts after injection of TAA mixed with Montanide and document tumor response in pts w/ measurable disease or time to progression in pts without measurable disease following injection of TAA mixed w/ Montanide.
Time frame: 2-4 weeks
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 26 Jan 2016.
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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.
Sharon Gardner, MD principal investigator
NYU Langone Medical Center
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 Montanide in people with Tumors, Central Nervous System, run by NYU Langone Health 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: finished, as of the sponsor's last update on 26 Jan 2016. 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 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?
The primary aim is to evaluate the safety of subcutaneous injections of tumor associated antigens (TAA) mixed with Montanide ISA-51VG in patients with recurrent or refractory brain tumors. (time frame: 2-4 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 26 Jan 2016.