Tumor Infiltrating Lymphocytes in Pediatric Malignant Solid Tumors: A Prospective Biobanking Study and Phase I Clinical Trial
H. Lee Moffitt Cancer Center and Research Institute
Summary
Part One of this study will determine the feasibility of creating Tumor-Infiltrating Lymphocyte (TIL) product prospectively from high-risk pediatric solid tumors. Part Two of this study will determine the safety of TIL therapy with lymphodepleting chemotherapy and post-TIL Interleukin-2 in high-risk pediatric solid tumors
Eligibility
- Age range
- 1–21 years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA Part One (Prospective biobanking study): * Patients must be ≥1 year to ≤ 21 years of age at time of enrollment to Part One. * Initial therapy patients: Patients with a histologic diagnosis of high-risk pediatric malignant solid tumors (pMST), defined as a pediatric malignant solid tumor outside of the central nervous system, newly-diagnosed or being treated with initial therapy, with expected 5-year Event-Free Survival (EFS) \<60%. Examples include: * High-risk neuroblastoma * Metastatic Ewing sarcoma * Metastatic osteosarcoma * Hepatoblastoma metastatic or not am…
Interventions
- BiologicalTumor Infiltrating Lymphocytes, Fludarabine, Cyclophosphamide, Interleukin-2
Lymphodepleting Chemotherapy with Fludarabine/Cyclophosphamide followed by TIL and Post-TIL Interleukin-2 (IL-2)
Location
- Johns Hopkins All Children's HospitalSt. Petersburg, Florida