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Trametinib for Brain Tumor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center, Hackensack, NJBrain Tumor+2 MoreTrametinib - Drug
Eligibility
1 - 25
All Sexes
What conditions do you have?
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Study Summary

This trial studies the side effects and best dose of two drugs, trametinib and everolimus, in treating pediatric and young adult patients with low grade gliomas that has come back (recurrent).

Eligible Conditions
  • Brain Tumor
  • WHO Grade II Glioma
  • Low Grade Glioma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Arm D: Personalized Intermittent Vismodegib (TGI model)
1
Trametinib
1
Capmatinib

Study Objectives

6 Primary · 0 Secondary · Reporting Duration: Up to 5 years

Up to 28 days
Dose limiting toxicities (DLTs) of the combination for both continuous and intermittent dosing schedules
Maximum tolerated dose (MTD) of trametinib in combination with everolimus for both continuous and intermittent dosing schedules
Recommended phase 2 dose (RP2D)
Day 30
Incidence of adverse events for both continuous and intermittent dosing schedules
Up to 5 years
Area Under the Curve (AUC) of trametinib and everolimus
Everolimus

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Arm D: Personalized Intermittent Vismodegib (TGI model)
1
Trametinib
1
Capmatinib

Side Effects for

Cohort D
47%Headache
47%Pyrexia
41%Diarrhoea
35%Constipation
35%Myalgia
35%Nausea
35%Vomiting
35%Chills
35%Arthralgia
29%Abdominal pain
29%Asthenia
24%Folliculitis
24%Gamma-glutamyltransferase increased
18%Weight decreased
18%Aphasia
18%Blood alkaline phosphatase increased
18%Decreased appetite
18%Rash
18%Oedema peripheral
18%Dry mouth
18%Fatigue
18%Aspartate aminotransferase increased
18%Alanine aminotransferase increased
18%Muscular weakness
18%Dizziness
18%Seizure
18%Cough
18%Dry skin
12%Insomnia
12%Epistaxis
12%Hypophosphataemia
12%Eyelid oedema
12%Ejection fraction decreased
12%Anaemia
12%Thrombocytopenia
12%Visual impairment
12%Urinary tract infection
12%Weight increased
12%Hypocalcaemia
12%Hypokalaemia
12%Back pain
12%Pain in extremity
12%Paraesthesia
12%Partial seizures
12%Alopecia
12%Pruritus
6%Bronchitis
6%Respiratory tract infection
6%Skin striae
6%Blood sodium increased
6%Lipase increased
6%Blood cholesterol increased
6%Blood potassium decreased
6%Tendonitis
6%Anxiety
6%Metrorrhagia
6%Rhinitis allergic
6%Dermatitis acneiform
6%Skin exfoliation
6%Nasal congestion
6%Generalised erythema
6%Muscle spasms
6%Visual field defect
6%Papilloma
6%Gastrointestinal haemorrhage
6%Neck pain
6%Abdominal pain upper
6%Acute kidney injury
6%Conjunctival irritation
6%Eye pruritus
6%Diplopia
6%Vision blurred
6%Vitreous detachment
6%Gastrooesophageal reflux disease
6%Pain
6%Xerosis
6%Cellulitis
6%Skin infection
6%Neutrophil count decreased
6%Dehydration
6%Musculoskeletal pain
6%Musculoskeletal chest pain
6%Motor dysfunction
6%Paresis
6%Sleep disorder
6%Erythema
6%Hot flush
6%Hypotension
6%Lymphoedema
6%Onychomycosis
6%Papule
6%Renal failure
6%Dry eye
6%Punctate keratitis
6%Visual acuity reduced
6%Abdominal pain lower
6%Faeces soft
6%Gastrointestinal disorder
6%Face oedema
6%Lung infection
6%Herpes zoster
6%Rash pustular
6%Hyperhidrosis
6%Ligament sprain
6%Amylase increased
6%Blood creatinine increased
6%Hypomagnesaemia
6%Hyponatraemia
6%Joint range of motion decreased
6%Intertrigo
6%Night sweats
6%Amnesia
6%Dysarthria
6%Pain of skin
6%Tonic clonic movements
6%Agitation
6%Confusional state
6%Dyspnoea
6%Productive cough
6%Aquagenic wrinkling of palms
6%Pruritus generalised
6%Skin lesion
6%Deep vein thrombosis
6%Presyncope
6%Temporal lobe epilepsy
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02039947) in the Cohort D ARM group. Side effects include: Headache with 47%, Pyrexia with 47%, Diarrhoea with 41%, Constipation with 35%, Myalgia with 35%.

Trial Design

1 Treatment Group

Treatment (trametinib, everolimus)
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Trametinib · No Placebo Group · Phase 1

Treatment (trametinib, everolimus)Experimental Group · 2 Interventions: Trametinib, Everolimus · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
FDA approved
Everolimus
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,310 Previous Clinical Trials
11,598,208 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,735 Previous Clinical Trials
3,543,976 Total Patients Enrolled
Pediatric Brain Tumor FoundationUNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
The Lilabean Foundation for Pediatric Brain Cancer ResearchUNKNOWN
Sabine Mueller5.01 ReviewsPrincipal Investigator - University of California, San Francisco
University of California, San Francisco
2 Previous Clinical Trials
124 Total Patients Enrolled

Eligibility Criteria

Age 1 - 25 · All Participants · 10 Total Inclusion Criteria

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References

Frequently Asked Questions

What potential dangers do individuals face when using Trametinib?

"Trametinib's safety is rated as a 1 since this trial falls under Phase 1, indicating that only minimal evidence exists to support its effectiveness and security." - Anonymous Online Contributor

Unverified Answer

Are there any eligibility requirements I must meet to be accepted into this clinical trial?

"This medical trial is recruiting 50 individuals with glioma between one year old and 25 years. The criteria to join the study necessitate that participants must have a histologically confirmed diagnosis of LGG (WHO grade I-II) or HGG (WHO Grade III-VI). Moreover, patients need to have received prior therapy other than surgery, such as chemotherapy, biologics, immunotherapy or radiotherapy before enrolling in this research project. Also required are snap frozen tissue samples for comprehensive genomic testing or results from similar tests previously conducted. Additionally those who had taken myelosuppressive anticancer drugs should've ceased their intake three" - Anonymous Online Contributor

Unverified Answer

How many individuals are partaking in this research endeavor?

"This clinical research is in search of 50 eligible patients, who are able to adhere to the inclusion criteria. Those interested may take part from medical centers such as University of Florida in Gainesville and Riley Hospital for Children in Indianapolis." - Anonymous Online Contributor

Unverified Answer

Does this research endeavor cater to individuals aged 85 and over?

"This medical trial mandates that participants must be between a year old and 25 years of age. 285 studies are available for minors while 1,270 can provide assistance to elderly individuals." - Anonymous Online Contributor

Unverified Answer

What pathologies is Trametinib commonly administered to address?

"Trametinib is a medication capable of treating unresectable melanoma, liver transplant rejection and renal allotransplant rejections." - Anonymous Online Contributor

Unverified Answer

Is this research being conducted in numerous hospitals across the North American region?

"The study is currently enrolling patients at University of Florida (Gainesville, FL), Riley Hospital for Children (Indianapolis, IN) and University of California San Francisco (San Francisco, CA). Additionally, there are 14 other medical centres included in the trial." - Anonymous Online Contributor

Unverified Answer

Are recruits welcome to join this experiment?

"Clinicaltrials.gov confirms that this medical research is still recruiting patients, having been first posted on December 9th 2020 and updated most recently on October 28th 2022." - Anonymous Online Contributor

Unverified Answer

Could you please summarize any prior research related to Trametinib?

"Trametinib was initially studied at Sheba Medical Center in 2008. Since then, 472 trials have been completed with 180 more actively recruiting clinical participants. The majority of these new studies are conducted out of Gainesville, Florida." - 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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