A Pilot Study of Tumor-Specific Peptide Vaccination and IL-2 With or Without Autologous T Cell Transplantation in Recurrent Pediatric Sarcomas
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|ClinicalTrials.gov Identifier: NCT00001564|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : December 3, 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|
|Actual Primary Completion Date :||October 25, 2007|
|Actual Study Completion Date :||October 25, 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|