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NCT01678352 · ClinicalTrials.gov registry record · Early Phase 1
Imiquimod and Tumor Lysate Vaccine Immunotherapy in Adults With High Risk or Recurrent Grade II Gliomas
A Early Phase 1 study, sponsored by Frank Lieberman.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 19
- Enrollment target
NCT01678352: Completed Early Phase 1 study, sponsored by Frank Lieberman.
NCT01678352 is a Early Phase 1 study that has completed, run by Frank Lieberman. The registered enrollment target is 19 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01678352, a Early Phase 1 study, has completed, sponsored by Frank Lieberman.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is a pilot study of a vaccination regime that is designed to efficiently induce anti-tumor T-cell responses in patients with WHO grade II glioma. The proposed regime with BTIC Lysate in combination with imiquimod, an FDA-approved immune response modifier will induce potent anti-glioma immune response with minimal or no toxicity.
Primary Outcome
The incidence and severity of adverse events associated with the vaccine regime will be assessed according to NCI's Common Terminology Criteria for Adverse Events V 4.0 (CTCAE), as follows: 1. . Grade 3-5 vaccine related allergic reaction 2. . Grade 3-5 organ toxicity (cardiac, dermatologic (excluding localized skin reaction), gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) not pre-existing or due to the underlying malignancy and occurring within 28 days of vaccination
Interventions
- DRUG Imiquimod
- BIOLOGICAL Tumor Lysate Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-10 |
| Est. Completion | 2018-11-08 |
| Phase | Early Phase 1 |
What the finished NCT01678352 record still lists
NCT01678352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Imiquimod is the first listed.
NCT01678352 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01678352 about?
NCT01678352 is a clinical study titled "Imiquimod and Tumor Lysate Vaccine Immunotherapy in Adults With High Risk or Recurrent Grade II Gliomas". This is a pilot study of a vaccination regime that is designed to efficiently induce anti-tumor T-cell responses in patients with WHO grade II glioma. The proposed regime with BTIC Lysate in combination with imiquimod, an FDA-approved immune response modifier will induce potent anti-glioma immune re...
What is the current status of trial NCT01678352?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 19 participants. The study started on 2012-10. Estimated completion is 2018-11-08.
What interventions are being tested in trial NCT01678352?
The interventions under investigation include: Imiquimod (DRUG), Tumor Lysate Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01678352?
This trial is sponsored by Frank Lieberman, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01678352's enrollment target sits among peer trials
19 1292nd of 2000 higher than 686 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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