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Osteosarcoma - Healing Genes
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Osteosarcoma

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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)


Phase 1

DESCRIPTION:

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.


PATIENT MUST:

  • 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:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Recovery of the blood for T-cell separation, selection and modification.
  3. No treatment will be required while the selected T-cells are genetically modified and then multiplied.
  4. Depending on the group assigned, the patient may have a round of chemotherapy or not.
  5. A single infusion of the modified cells will be given.
  6. Within either 48 hours or 42 days later (depending on the group assigned), varicella vaccine will be given.
  7. Initial follow-up will be 14 weeks, with long term follow up for 15 years.

LOCATIONS AND CONTACTS:

The study sites are at the Houston Methodist Hospital, Map, and Texas Children’s Hospital, Map.

Contact: Sarah Whittle, MD  |  832-824-1471  |  [email protected]

Contact: Lisa L Wang  |  832-824-4822  |  [email protected]

 

SPONSOR INFORMATION:

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

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT01953900

 

 

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