NCT02444546

Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors

Phase 1 Study of Replication Competent Reovirus (Reolysin®) in Combination With GM-CSF in Pediatric Patients With Relapsed or Refractory Brain Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 10 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and the best dose of wild-type reovirus (viral therapy) when given with sargramostim in treating younger patients with high grade brain tumors that have come back or that have not responded to standard therapy. A virus, called wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Sargramostim may increase the production of blood cells and may promote the tumor cell killing effects of wild-type reovirus. Giving wild-type reovirus together with sargramostim may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To define the maximum tolerated dose (MTD) and describe the toxicities of wild-type reovirus (Reolysin) when given once a day for three days following two days of treatment with sargramostim (GM-CSF). SECONDARY OBJECTIVES: I. To assess the safety, tolerability and adverse events in the patient population. II. To assess the median overall survival time in this patient population. III. To assess the median progression free survival time in this patient population. TERTIARY OBJECTIVES: I. To determine whether there is a correlation between antibody responsiveness to the virus and a positive tumor response to Reolysin in patients who receive the virus following treatment with GM-CSF. II. To determine whether there is a correlation between an increased number of circulating monocytes and a positive tumor response to Reolysin in patients who receive the virus following treatment with GM-CSF. III. To explore the possible predictive value of monocyte numbers in response to Reolysin + GM-CSF therapy. OUTLINE: This is a dose-escalation study of wild-type reovirus. Patients receive sargramostim subcutaneously (SC) daily on days 1 and 2 and wild-type reovirus intravenously (IV) over 60 minutes on days 3-5. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for up to 2 years.

Conditions

• Childhood Astrocytoma
• Childhood Atypical Teratoid/Rhabdoid Tumor
• Diffuse Intrinsic Pontine Glioma
• Glioma
• Recurrent Childhood Anaplastic Oligodendroglioma
• Recurrent Childhood Brain Neoplasm
• Recurrent Childhood Glioblastoma
• Recurrent Childhood Medulloblastoma
• Recurrent Primitive Neuroectodermal Tumor
• Refractory Brain Neoplasm

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Sargramostim	Given SC
BIOLOGICAL	Wild-type Reovirus	Given IV

Timeline

• Start date: 2015-06-21
• Primary completion: 2018-07-13
• Completion: 2022-11-21
• First posted: 2015-05-14
• Last updated: 2023-04-24

Locations

1 site across 1 country: United States