iC9-GD2-CAR-VZV-CTLs/Refractory or Metastatic GD2-positive Sarcoma and Neuroblastoma (VEGAS)
Vaccination to Enhance the Anti-Tumor Activity of GD2 Chimeric Antigen Receptor-Expressing, VZV-Specific T Cells in Subjects With Advanced Sarcomas and Neuroblastoma (VEGAS)
The Baylor College of Medicine is conducting a trial of an experimental treatment for recurrent neuroblastoma and osteosarcoma. This trial uses a validated cancer treatment of gene-modified immunotherapy, removing immune T-cells from the patient and programming them to recognize and attack their cancer. It also combines the treatment with a preferential choice of T-cells that recognize varicella (chicken pox) virus, because those cells are known to persist for many years and may extend the effectiveness of the cancer therapy. This treatment will involve a varicella vaccine booster and some participants will undergo a chemotherapy treatment before the T-cells are returned.
- Have a diagnosis of relapsed or refractory osteosarcoma or neuroblastoma
- Have been previously vaccinated or infected with varicella zoster virus (chicken pox)
- Be willing to use birth control, if sexually active
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- Recovery of the blood for T-cell separation, selection and modification.
- No treatment will be required while the selected T-cells are genetically modified and then multiplied.
- Depending on the group assigned, the patient may have a round of chemotherapy or not.
- A single infusion of the modified cells will be given.
- Within either 48 hours or 42 days later (depending on the group assigned), varicella vaccine will be given.
- Initial follow-up will be 14 weeks, with long term follow up for 15 years.
LOCATIONS AND CONTACTS:
Sarah Whittle, MD | 832-824-1471 | [email protected]
Lisa L Wang | 832-824-4822 | [email protected]
Baylor College of Medicine
The National Cancer Institute (NCI)
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital System
Texas Children’s Hospital
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