A Pilot Study of Autologous T-Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas
Completed · Phase 2
Conditions studied: Ewing's Sarcoma, Rhabdomyosarcoma
In brief
This is a single arm study. The tumor specimen is analyzed for the presence of a fusion protein which corresponds to available peptides. Patients undergo T cell harvest 10 days after an initial priming peptide-pulsed antigen presenting cell (APC) vaccine is performed. Fresh APCs are utilized for initial priming vaccination. All subsequent vaccinations will use cryopreserved APCs. Minimum number of APCs administered per vaccination is 100,000/kg and maximum is 100,000,000/kg. Patients undergo cytoreductive therapy for the treatment of their particular malignancy. This therapy usually consists of multiagent chemotherapy in the context of a separate protocol. Following chemotherapy, infusion of harvested T cells followed by infusion of peptide-pulsed APC vaccinations occurs every 6 weeks for a total of 3 post-priming vaccinations. Influenza vaccine is administered by intramuscular injection concurrent to peptide-pulsed APC vaccines. Interleukin -2 (IL-2) is administered as a continuous intravenous (IV) infusion for 4 days/week for 3 successive weeks starting on the same day as T cell /peptide-pulsed infusions.
Key facts
- Study ID
- NCT00001566
- Run by
- National Cancer Institute (NCI)
- People needed
- 42
- Starts
- 1996-12-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2012-06-15
Who can join
Age: 5 and older, up to 35. 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 will be excluded due to the untoward risks to personnel working with blood specimens.
- 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-Barre 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
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.