CClinicalTrials.gg
CompletedNCT00935545Updated Jan 26, 2016

Study of Peptide Vaccination With Tumor Associated Antigens Mixed With Montanide in Patients With CNS Tumors

A Phase 1 interventional study of Montanide in Tumors, Central Nervous System, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2016-01-26.

Sponsored by NYU Langone Health · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
Up to 21 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Tumors, Central Nervous System

Keywords

  • Brain Tumors
  • High Grade
  • CNS
03

In context

Central Nervous System Neoplasms

673 studies on the registry are indexed under Central Nervous System Neoplasms; 68 are open to participants now.

This study's enrollment of 15 is below the median of 35 across 464 interventional studies indexed under Central Nervous System Neoplasms.

Browse Central Nervous System Neoplasms studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. 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.
  3. Patients must be HLA A*0201 positive.
  4. Age \< 21 years
  5. Patients must weigh > 15kg due to the amount of blood required for immune function studies.
  6. 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.
  7. 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

  8. Life expectancy > 3 months
  9. 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)
  10. Measurable disease is not required.
  11. Informed consent must be signed by the patient or legal representative.

Exclusion criteria

Exclusion Criteria

  1. Serious illness, eg, uncontrolled infections requiring antibiotics.
  2. History of immunodeficiency disease (such as HIV) or autoimmune disease except vitiligo.
  3. Concomitant treatment with systemic corticosteroids greater than physiologic doses. Topical (but not at the proposed vaccination site) or inhalational steroids are permitted.
  4. Participation in any other clinical trial involving another investigational agent within 4 weeks prior the first dose of study agent.
  5. Pregnant or lactating women are not permitted.
  6. Women of child-bearing potential not using medically acceptable means of contraception.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Open Label

    Biological: Montanide

Interventions

  • BiologicalMontanide

    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.

    Also known as: Montanide ISA-51 VG

06

What researchers measure

Primary outcomes

  1. 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

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.

    Time frame: 2-4 weeks

07

Study locations

1 site
  • NYU Langone Medical Center
    New York, New York 10016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00935545
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Jul 9, 2009
Start date
Jul 2009
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Jan 26, 2016

Study contacts

Sharon Gardner, MD
principal investigator · NYU Langone Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion