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Anti-diabetic drug

Metformin for Brain Tumor

Phase 1
Waitlist Available
Led By Damon Reed, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average of 3 months
Awards & highlights

Study Summary

This trial is testing if a higher dose of metformin, given with other cancer drugs, is safe for children with solid tumors that have come back or haven't responded to other treatments.

Eligible Conditions
  • Brain Tumor
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average of 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and average of 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Secondary outcome measures
Metformin
Number of Participants with Antitumor Activity
Pharmacodynamics
+1 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Metformin in Combination with VITExperimental Treatment4 Interventions
Participants will receive metformin in combination with vincristine, irinotecan and temozolomide (VIT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Vincristine
2003
Completed Phase 4
~2910
Metformin
2006
Completed Phase 4
~2430
Irinotecan
2017
Completed Phase 4
~2680

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,466 Total Patients Enrolled
Pediatric Cancer FoundationOTHER
3 Previous Clinical Trials
42 Total Patients Enrolled
Jonathan Gill, M.D.Study ChairThe Children's Hospital at Montefiore, Pediatric Cancer Foundation, Sunshine Project

Frequently Asked Questions

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

What are the eligibility requirements for participation in this trial?

"26 individuals must satisfy the eligibility criteria of this medical study, which requires a diagnosis of brain cancer and an age between 1 year old and 18."

Answered by AI

Does this medical trial accept participants aged fifty or older?

"The requirements for this medical trial necessitate that the patients are between 1 and 18 years old. Clinicialtrials.gov features 543 studies specifically designed to aid individuals under 18 while 3313 trials cater towards people over 65."

Answered by AI

How many healthcare facilities are participating in this trial?

"This experiment is being conducted at a total of 14 sites, including Saint Petersburg, Columbus and Tampa. To reduce unnecessary travel time, it's recommended to choose the closest location if you are signing up for this trial."

Answered by AI

Are there any prior experiments that have involved Metformin?

"Presently, a vast array of trials for Metformin are running; 818 in total. Of those studies, 199 have achieved Phase 3 status and are being conducted at 27910 sites located primarily around Houston, Texas."

Answered by AI

What is the current enrollment rate for this research project?

"Unfortunately, recruitment for this medical trial has been closed since August 15th 2022. As of now, there are 2896 studies recruiting patients with brain related issues and 818 trials requiring participants to take Metformin."

Answered by AI

In what medical cases does Metformin usually feature?

"Metformin is an appropriate form of treatment for nitrosourea therapy, physical activity, and the late stages of mycosis fungoides."

Answered by AI

Are there any open slots for participants in this investigation?

"This investigation is no longer seeking participants; the trial was first posted on September 24th 2012 and has now been superseded. Currently, 2896 clinical trials related to brain diseases are recruiting patients as well 818 studies regarding Metformin's efficacy in treating various maladies."

Answered by AI

Has the FDA given its stamp of approval to Metformin?

"Metformin's safety has been backed by limited research, therefore it was allocated a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Metformin in Children With Relapsed or Refractory Solid Tumors
2012. "Metformin in Children With Relapsed or Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01528046.
~2 spots leftby Apr 2025
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