A Phase 1 Study of a Combined Cytotoxic and Immune-Stimulatory Therapy in Pediatric and Young Adult Patients With Recurrent, Primary Malignant Brain Tumors

Summary

This phase I trial tests the safety, side effects and best dose of AdV-HSV1-TK and AdV-Flt3L in combination with valacyclovir for the treatment of patients with primary cancerous (malignant) brain tumors that can be removed by surgery (resectable) and that have come back after a period of improvement (recurrent). AdV-HSV1-TK and AdV-Flt3L use a virus modified in the laboratory to kill tumor cells and stimulate the immune system to recognize the tumor cells as "invaders" which can lead to tumor shrinkage. For this process to work, an oral anti-herpes medication called valacyclovir is also needed. Giving AdV-HSV1-TK, AdV-Flt3L and valacyclovir may be safe, tolerable and/or effective in treating patients with resectable, recurrent primary malignant brain tumors.

Eligibility

Age range

3–39 years

Sex

All

Healthy volunteers

No

Interventions

• Genetic
  Ad-hCMV-Flt3L

  Given via injection

• Genetic
  Ad-hCMV-TK

  Given via injection

• Procedure
  Biospecimen Collection

  Undergo blood sample collection

• Procedure
  Magnetic Resonance Imaging

  Undergo MRI

• Other
  Survey Administration

  Ancillary studies

• Procedure
  Tumor Resection

  Undergo standard of care tumor resection

• Drug
  Valacyclovir

  Given PO

Location