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NCT00766753 · ClinicalTrials.gov registry record · Phase 1
Vaccination-Dendritic Cells With Peptides for Recurrent Malignant Gliomas
A Phase 1 study of Malignant Glioma, sponsored by Frank Lieberman.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT00766753: Completed Phase 1 study of Malignant Glioma, sponsored by Frank Lieberman.
NCT00766753 is a Phase 1 study of Malignant Glioma that has completed, run by Frank Lieberman. The registered enrollment target is 22 participants, below the 91-participant average among 40 other Malignant Glioma trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00766753, a Phase 1 study of Malignant Glioma, has completed, sponsored by Frank Lieberman.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-institution Phase I/II study designed to evaluate the safety and induction of an immune response, and preliminary clinical response of vaccinations with Type-1 alpha-DCs (alpha-DC1) loaded with glioma-associated antigen (GAA) epitopes and administration of poly-ICLC in patients with recurrent malignant gliomas. Approximately 30 subjects will be enrolled in this study at UPMC/UPCI Hillman Cancer Center. The study participants in this trial will be HLA-A2 positive male or female adults over 18 years of age. The primary objective is to establish the safety of this approach. The endpoints will be to determine the maximum tolerated dose (MTD) of alpha-DC1 vaccines in combination with a fixed dose of poly-ICLC, using standard criteria and close clinical followups. The secondary objectives are 1) to assess the immunological response against GAAs in patients with recurrent malignant gliomas immunized with DCs loaded with GAA-derived peptides using enzyme-linked immuno-spot (ELISPOT), delayed-type hypersensitivity (DTH) and tetramer assays; and 2) to assess the preliminary anti-tumor clinical activity of the vaccines as measured by radiological response (MRI), overall survival, and 4- and 6-month progression-free survival (PFS).
Primary Outcome
Number of participants who experienced treatment-related Dose Limiting Toxicities (DLT) at any dose level.
Conditions Studied
Interventions
- BIOLOGICAL Dendritic vaccine pulsed with multiple peptides
- BIOLOGICAL The first booster vaccine phase:
- BIOLOGICAL The second booster vaccine phase:
Study Locations (1)
Pennsylvania
- Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2006-12 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT00766753 record still lists
NCT00766753 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 91-participant average among 40 other Malignant Glioma trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Malignant Glioma appearing as the primary indexed condition, and to 3 interventions - of which Dendritic vaccine pulsed with multiple peptides is the first listed.
NCT00766753 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00766753 about?
NCT00766753 is a clinical study titled "Vaccination-Dendritic Cells With Peptides for Recurrent Malignant Gliomas". This is a single-institution Phase I/II study designed to evaluate the safety and induction of an immune response, and preliminary clinical response of vaccinations with Type-1 alpha-DCs (alpha-DC1) loaded with glioma-associated antigen (GAA) epitopes and administration of poly-ICLC in patients with...
What is the current status of trial NCT00766753?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2006-12. Estimated completion is 2016-06.
What conditions does trial NCT00766753 study?
This clinical trial studies the following conditions: Malignant Glioma.
What interventions are being tested in trial NCT00766753?
The interventions under investigation include: Dendritic vaccine pulsed with multiple peptides (BIOLOGICAL), The first booster vaccine phase: (BIOLOGICAL), The second booster vaccine phase: (BIOLOGICAL).
Who is sponsoring clinical trial NCT00766753?
This trial is sponsored by Frank Lieberman, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00766753 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00766753's enrollment target sits among peer trials
22 31st of 40 higher than 8 of 40 other Malignant Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Glioma 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.
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