At a glance
ClinicalIndex Comparison Record- ✓Fusion protein-bearing metastatic Ewing's sarcoma family tumors or alveolar rhabdomyosarcoma with documented tumor-specific fusion protein by RT-PCR
- ✓Stage IV or metastatic disease at initial presentation prior to any cytoreductive therapy
- ✓Recurrent disease with prior treatment completion ≥1 year ago (age >5 years) or ≥6 months ago (age ≤5 years)
- ✓Age ≤35 years at initial diagnosis
- ✕Pregnant or lactating women
- ✕HIV infection
- ✕Hepatitis B or C infection
- ✕Require daily oral corticosteroid therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of Autologous T-Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas
In Brief
A Phase 2 clinical trial evaluating therapeutic autologous dendritic cells, indinavir sulfate, and 1 other intervention for Ewing's Sarcoma and Rhabdomyosarcoma. Completed, enrolled 42 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
3 syringes containing 1 x 10\^6peptide pulsed dendritic cells
Oral dose, 350 mg/m\^2 administered every 8 hours. Maximum dose is 800 mg every 8 hours.
Harvested autologous T cells, minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.