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Virus Therapy

Wild-type Reovirus for Diffuse Intrinsic Pontine Glioma

Phase 1
Waitlist Available
Led By Richard Bram
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have no known curative therapy available
Life expectancy >= 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a virus that's been changed to see if it can kill tumor cells without harming normal cells, and also testing a drug that may help increase the virus's tumor-killing effects.

Eligible Conditions
  • Diffuse Intrinsic Pontine Glioma
  • Childhood Brain Tumors
  • Childhood Astrocytoma
  • Primitive Neuroectodermal Tumor
  • Glioblastoma
  • Oligodendroglioma
  • Atypical Teratoid/Rhabdoid Tumor
  • Medulloblastoma
  • Brain Tumor

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
There are no other known treatments that can cure your medical condition.
Select...
You are expected to live for at least three more months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD, based on the incidence of dose-limiting toxicity (DLT) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
Secondary outcome measures
Adverse event profile
Objective responses
Overall survival
+5 more
Other outcome measures
Immunologic parameters
Reovirus immune status

Side effects data

From 2016 Phase 2 trial • 73 Patients • NCT01280058
56%
Neutropenia
42%
Neutrophil count decreased
33%
Leukopenia
28%
White blood cell decreased
28%
Platelet count decreased
28%
Thrombocytopenia
28%
Anemia
19%
Blood bilirubin increased
19%
Nausea
17%
Abdominal pain
17%
Fatigue
14%
Dyspnea
14%
Vomiting
11%
Acute kidney injury
11%
Thromboembolic event
11%
Febrile Neutropenia
11%
Confusion
11%
Hypokalemia
11%
Infection
8%
Bile duct stenosis
8%
Aspartate aminotransferase increased
8%
Alanine aminotransferase increased
8%
Sepsis
8%
Cardiac troponin I increaesd
8%
Urinary Tract Infection
8%
Ascites
6%
Peripheral sensory
6%
Skin Infection
6%
Dizziness
6%
Abdominal distension
6%
Diarrhea
6%
Atrial fibrillation
6%
Transient ischemic attacks
6%
Hypertension
6%
Pain
6%
Edema limbs
6%
Respiratory failure
6%
Infections
6%
Dehydration
3%
Postoperative hemorrhage
3%
Fracture
3%
Alkaline phosphatase increased
3%
Cardiac arrest
3%
Upper Respiratory Infection
3%
Lung Infection
3%
Pancreatitis
3%
Sinus tachycardia
3%
Lower gastrointestional hemorrhage
3%
Hypostension
3%
Injury, poisoning and procedural complications
3%
Device related infection
3%
Rectal hemorrhage
3%
Chest pain-cardiac
3%
Constipation
3%
Fever
3%
Gastric hemorrhage
3%
Gastric ulcer
3%
Infusion related reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel)
Arm B (Carboplatin, Paclitaxel)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (sargramostim, wild-type reovirus)Experimental Treatment3 Interventions
Patients receive sargramostim SC daily on days 1 and 2 and wild-type reovirus 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
FDA approved
Wild-type Reovirus
2015
Completed Phase 2
~180

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,636 Previous Clinical Trials
40,929,543 Total Patients Enrolled
15 Trials studying Diffuse Intrinsic Pontine Glioma
1,002 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Mayo ClinicLead Sponsor
3,193 Previous Clinical Trials
3,759,400 Total Patients Enrolled
Richard BramPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might I be a suitable contender for participating in this clinical trial?

"To be eligible for this research, an individual must have a diagnosis of diffuse intrinsic pontine glioma and fall within the specified age range (10-21 years old). The clinical trial is looking to admit 6 patients."

Answered by AI

What safety protocols must be followed when administering Wild-type Reovirus to patients?

"As this trial is in the early stages of Phase 1, there are limited datapoints to support efficacy and safety; thus Wild-type Reovirus received a score of 1."

Answered by AI

For which health conditions is Wild-type Reovirus an efficacious treatment?

"Wild-type Reovirus is a helpful therapeutic agent for patients suffering from severe infection, Hodgkin's lymphoma, and post bone marrow transplantation."

Answered by AI

What other investigations have been conducted concerning the effects of Wild-type Reovirus?

"Currently, 43 clinical trials involving Wild-type Reovirus are underway. 5 of these tests have entered Phase 3, and 1888 different medical sites across the globe are running studies for this therapy. The majority of operations related to it can be found in Seattle, Washington."

Answered by AI

Does the eligibility criteria of this clinical trial include individuals below 70 years old?

"Based on the eligibility criteria, individuals between 10 and 21 years old are authorized to partake in this clinical trial."

Answered by AI

What is the maximum capacity of individuals taking part in this clinical study?

"Unfortunately, this trial is no longer open for recruitment. It was initiated on June 21st 2015 with the last edit occurring on September 8 2020. If you are looking to join other trials related to diffuse intrinsic pontine glioma, there are currently 4146 studies accepting patients and 43 more recruiting participants for Wild-type Reovirus research."

Answered by AI

Is enrollment for this research still in progress?

"According to clinicaltrials.gov, this trial is no longer accepting participants; the study was initially advertised on June 21st 2015 and last revised on September 8th 2022. Fortunately, there are a plethora of other trials which require volunteers right now - 4189 opportunities in total."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors
2015. "Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02444546.
~1 spots leftby Apr 2025
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