A Pilot Study of Tumor-Specific Peptide Vaccination and IL-2 With or Without Autologous T Cell Transplantation in Recurrent Pediatric Sarcomas
Completed · Phase 2
Conditions studied: Ewing's Sarcoma, Rhabdomyosarcoma
In brief
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.
Key facts
- Study ID
- NCT00001564
- Run by
- National Cancer Institute (NCI)
- People needed
- 30
- Starts
- 1996-12-23
- Expected to finish
- 2007-10-25
- Last updated by the study team
- 2019-11-29
Who can join
Age: any, up to 30. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Women who are pregnant or lactating.
- Patients with human immunodeficiency virus infection due to confounding effects on immune function. Patients with hepatitis B or hepatitis C infection.
- Patients who require daily oral corticosteroid therapy for any underlying disease will be excluded. Topical or inhaled corticosteroids are permitted.
- Patients who are allergic to eggs, egg products, or thimerosal, or have a history of Guillain-Bare syndrome may be enrolled on study but are ineligible to receive the influenza vaccine.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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