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NCT00935545 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by NYU Langone Health.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target

NCT00935545: Completed Phase 1 study, sponsored by NYU Langone Health.

NCT00935545 is a Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00935545, a Phase 1 study, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

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.

Interventions

  • BIOLOGICAL Montanide

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2009-07
Est. Completion 2014-01
Phase Phase 1
NYU Langone Health

1,164 total trials

What the finished NCT00935545 record still lists

NCT00935545 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 1 intervention - of which Montanide is the first listed.

NCT00935545 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00935545 about?

NCT00935545 is a clinical study titled "Study of Peptide Vaccination With Tumor Associated Antigens Mixed With Montanide in Patients With CNS 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 b...

What is the current status of trial NCT00935545?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2009-07. Estimated completion is 2014-01.

What interventions are being tested in trial NCT00935545?

The interventions under investigation include: Montanide (BIOLOGICAL).

Who is sponsoring clinical trial NCT00935545?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00935545's enrollment target sits among peer trials

15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00935545, the US trial registry maintained by the National Library of Medicine. NCT00935545 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.