A Pilot Study of Tumor-Specific Peptide Vaccination and IL-2 With or Without Autologous T Cell Transplantation in Recurrent Pediatric Sarcomas
|ClinicalTrials.gov Identifier: NCT00001564|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : February 19, 2018
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Ewing's Sarcoma Rhabdomyosarcoma||Drug: EF-1 Peptide Drug: EF-2 Peptide Drug: PXFK Peptide Drug: E7 Peptide Drug: IL-2 Drug: IL-4 Drug: GM-CSF Drug: CD40 Ligand||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Official Title:||A Pilot Study of Tumor-Specific Peptide Vaccination and IL-2 With or Without Autologous T Cell Transplantation in Recurrent Pediatric Sarcomas|
|Study Start Date :||December 23, 1996|
|Primary Completion Date :||October 25, 2007|
|Study Completion Date :||October 25, 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001564
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Crystal L Mackall, M.D.||National Cancer Institute (NCI)|