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

NCT02444546 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-04-24

No results posted yet for this study

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.

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

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Sargramostim

Given SC

BIOLOGICAL

Wild-type Reovirus

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Richard Bram · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-21
Primary Completion
2018-07-13
Completion
2022-11-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02444546 on ClinicalTrials.gov