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NCT00001564 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study of Tumor-Specific Peptide Vaccination and IL-2 With or Without Autologous T Cell Transplantation in Recurrent Pediatric Sarcomas
A Phase 2 study of Rhabdomyosarcoma and Ewing's Sarcoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00001564 is a Phase 2 study of Rhabdomyosarcoma and Ewing's Sarcoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 68-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001564, a Phase 2 study of Rhabdomyosarcoma and Ewing's Sarcoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Arm A: Peripheral blood apheresis by harvesting chemotherapy-naive T cells and populations enriched for professional APCs. T cells and APCs are separated from the apheresis product using countercurrent centrifugal elutriation and a monocyte rich fraction is collected. Autologous T cell transplantation during immunotherapy. Arm B: Cell harvesting is performed as soon as possible. Both Arm A and B: Patients receive intravenous infusion of irradiated peptide-pulsed antigen presenting cell vaccination (APC) products as well as intramuscular injection of influenza vaccine on the same day. Recombinant human IL-2 is administered within 4 hours of the peptide pulsed vaccine by continuous intravenous infusion for 4 days per week for 3 successive weeks. Primary toxic effect of this therapy is expected to be related to the IL-2 therapy. Patients with Grade 2 neurologic or cardiac or any Grade 3 or 4 toxic effects will discontinued IL-2 therapy. If toxic effect is not resolved in 72-hours, the patient may remain on study but will not receive any further IL-2.
Conditions Studied
Interventions
- DRUG IL-2
- DRUG EF-1 Peptide
- DRUG EF-2 Peptide
- DRUG PXFK Peptide
- DRUG E7 Peptide
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 1996-12-23 |
| Est. Completion | 2007-10-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001564
The ClinicalTrials.gov registry entry for NCT00001564 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 68-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (56% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Rhabdomyosarcoma appearing as the primary indexed condition, and to 5 interventions - of which IL-2 is the first listed.
NCT00001564 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001564 about?
NCT00001564 is a clinical study titled "A Pilot Study of Tumor-Specific Peptide Vaccination and IL-2 With or Without Autologous T Cell Transplantation in Recurrent Pediatric Sarcomas". Arm A: Peripheral blood apheresis by harvesting chemotherapy-naive T cells and populations enriched for professional APCs. T cells and APCs are separated from the apheresis product using countercurrent centrifugal elutriation and a monocyte rich fraction is collected. Autologous T cell transplant...
What is the current status of trial NCT00001564?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 1996-12-23. Estimated completion is 2007-10-25.
What conditions does trial NCT00001564 study?
This clinical trial studies the following conditions: Rhabdomyosarcoma, Ewing's Sarcoma.
What interventions are being tested in trial NCT00001564?
The interventions under investigation include: IL-2 (DRUG), EF-1 Peptide (DRUG), EF-2 Peptide (DRUG), PXFK Peptide (DRUG), E7 Peptide (DRUG).
Who is sponsoring clinical trial NCT00001564?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001564 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.