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Selumetinib Sulfate for Low Grade Glioma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Cedars Sinai Medical Center, Los Angeles, CALow Grade Glioma+3 MoreSelumetinib Sulfate - Drug
Eligibility
2 - 21
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether selumetinib is as effective as the standard treatment (carboplatin and vincristine) for low-grade glioma. It will also compare the side effects of the two treatments.

Eligible Conditions
  • Low Grade Glioma
  • Metastatic Low Grade Glioma
  • Low Grade Astrocytoma
  • Metastatic Low Grade Astrocytoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
eugenol based zinc oxide and Ferric Sulfate
1
Selumetinib
1
EAY191-E5 Cohort II (sotorasib)

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 10 years

Week 48
Change in motor function
Month 12
Number of patients who experience an improvement in visual acuity (VA)
Month 60
Change in QOL scores over time
Change in neurocognitive functioning scores over time
Month 9
Change in quality of life (QOL)
Baseline and 9-months
Change in executive function
Up to 10 years
Radiographic tumor response rate
Year 10
Event-free survival (EFS)
Overall survival (OS)
Month 9
Processing speed function

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
eugenol based zinc oxide and Ferric Sulfate
1
Selumetinib
2
EAY191-E5 Cohort II (sotorasib)

Side Effects for

75mg Selumetinib Sulfate Twice Daily Follow/by 50mg TwiceDaily
100%Pruritus
100%Rash maculo-papular
100%Alanine aminotransferase increased
100%Flatulence
100%Aspartate aminotransferase increased
100%Hypertension
50%Edema face
50%Hyperglycemia
50%Hypocalcemia
50%Edema limbs
50%Gastroesophageal reflux disease
50%Hypoalbuminemia
50%Platelet count decreased
50%Abdominal distension
50%Paresthesia
50%Sore throat
50%Muscle weakness trunk
50%Neutrophil count decreased
50%Hypercalcemia
50%Fatigue
50%Dyspnea
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03040986) in the 75mg Selumetinib Sulfate Twice Daily Follow/by 50mg TwiceDaily ARM group. Side effects include: Pruritus with 100%, Rash maculo-papular with 100%, Alanine aminotransferase increased with 100%, Flatulence with 100%, Aspartate aminotransferase increased with 100%.

Trial Design

2 Treatment Groups

Arm I (vincristine sulfate, carboplatin)
1 of 2
Arm II (selumetinib sulfate)
1 of 2

Active Control

Experimental Treatment

220 Total Participants · 2 Treatment Groups

Primary Treatment: Selumetinib Sulfate · No Placebo Group · Phase 3

Arm II (selumetinib sulfate)Experimental Group · 5 Interventions: Magnetic Resonance Imaging, Biospecimen Collection, Quality-of-Life Assessment, Questionnaire Administration, Selumetinib Sulfate · Intervention Types: Procedure, Procedure, Other, Other, Drug
Arm I (vincristine sulfate, carboplatin)ActiveComparator Group · 6 Interventions: Magnetic Resonance Imaging, Biospecimen Collection, Quality-of-Life Assessment, Carboplatin, Vincristine Sulfate, Questionnaire Administration · Intervention Types: Procedure, Procedure, Other, Drug, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Biospecimen Collection
2004
Completed Phase 1
~670
Hydrogen
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,153 Previous Clinical Trials
41,162,113 Total Patients Enrolled
Peter M de BlankPrincipal InvestigatorChildren's Oncology Group

Eligibility Criteria

Age 2 - 21 · All Participants · 28 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you have a seizure disorder, you must not have had a significant increase in seizure frequency in the past 2 weeks.
You can participate if you have cancer that has spread to other parts of your body or have multiple tumors in your brain.
You must be able to swallow pills without crushing or chewing them.
References

Frequently Asked Questions

Does this experiment only test on individuals below a certain age?

"This trial is open to anyone who falls in the 2-21 age bracket." - Anonymous Online Contributor

Unverified Answer

How can I sign up for this opportunity to test a new treatment?

"Children aged 2-21 who have been diagnosed with astrocytoma are eligible for this clinical trial. Currently, the research team is looking to recruit approximately 220 patients." - Anonymous Online Contributor

Unverified Answer

What are the harmful side effects of Selumetinib Sulfate?

"Selumetinib Sulfate is rated as a 3 in terms of safety by our team at Power. This is due to the fact that this drug has completed Phase 3 trials, thus there is some data supporting both efficacy and safety." - Anonymous Online Contributor

Unverified Answer

In how many different settings is this research being conducted?

"100 patients are needed for this clinical trial, which is being conducted at Ascension Saint Vincent Indianapolis Hospital in Indianapolis, University of Iowa/Holden Comprehensive Cancer Center in Iowa City, Cedars Sinai Medical Center in Los Angeles, and 100 other locations." - Anonymous Online Contributor

Unverified Answer

Are there any patients presently enrolled in this clinical trial?

"Yes, according to the latest information on clinicaltrials.gov, this study is still recruiting patients. It was first posted on 1/3/2020, and the most recent update was on 11/8/2022. The trial needs 220 more participants across 100 locations." - Anonymous Online Contributor

Unverified Answer

What are the most similar medical studies to Selumetinib Sulfate?

"Selumetinib sulfate was first studied in 2001 at the UCSF Helen Diller Family Comprehensive Cancer Center. Over 1500 studies have been completed thus far, with nearly 1000 more currently underway--a large number of which are based out of Indianapolis, Indiana." - Anonymous Online Contributor

Unverified Answer

What illnesses does Selumetinib Sulfate help to alleviate?

"While often used to treat advanced sarcoma, selumetinib sulfate can also be given as initial treatment, or to patients with acquired immunodeficiency syndrome or advanced thymoma." - Anonymous Online Contributor

Unverified Answer

How many people are involved in this clinical trial?

"The data on clinicaltrials.gov does indeed show that this study is recruiting participants at the moment. The trial was first posted on January 3rd, 2020 and was most recently updated on November 8th, 2022. Currently, the study is looking for 220 participants across 100 different locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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