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mTOR Inhibitor

Temsirolimus Infusion for Brain Tumor

Phase < 1
Recruiting
Led By Nader Sanai, MD
Research Sponsored by Nader Sanai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (intraoperative)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if a drug can treat recurrent high-grade brain tumors. Patients receive an infusion of the drug on the day of surgery.

Who is the study for?
Adults over 18 with a specific type of brain tumor called high-grade glioma that's come back after initial treatment can join. They must have completed the Stupp regimen, not be pregnant or able to become pregnant, and agree to use effective contraception. People with serious medical conditions like active infections or lung disease, recent other trials, or live vaccinations are excluded.
What is being tested?
This trial tests Temsirolimus delivered directly into the artery feeding the tumor or through an IV on the same day as surgery to remove the tumor. It's for those whose tumors show certain changes in their mTOR pathway and is designed to find out how different doses affect patients.
What are the potential side effects?
Temsirolimus may cause side effects such as allergic reactions due to its components (like polysorbate 80), issues from where it's infused, increased risk of infection, and possibly lung problems like interstitial lung disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (intraoperative)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (intraoperative) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tumor pharmacokinetics (PK) of temsirolimus
Secondary study objectives
Pharmacodynamic effects of temsirolimus

Side effects data

From 2013 Phase 2 trial • 86 Patients • NCT01256385
75%
Fatigue
65%
Anemia
48%
Hyperglycemia
43%
Lymphocyte count decreased
38%
Anorexia
35%
Platelet count decreased
35%
Constipation
35%
Cough
35%
Nausea
30%
Pain
30%
Mucositis oral
28%
Dyspnea
28%
White blood cell decreased
28%
Hypoalbuminemia
25%
Alanine aminotransferase increased
25%
Cholesterol high
25%
Hypertriglyceridemia
23%
Dysphagia
20%
Depression
20%
Fever
20%
Hypophosphatemia
20%
Weight loss
18%
Alkaline phosphatase increased
18%
Aspartate aminotransferase increased
18%
Non-cardiac chest pain
18%
Insomnia
18%
Headache
18%
Hyponatremia
18%
Hypocalcemia
18%
Hypokalemia
15%
Edema face
15%
Vomiting
15%
Creatinine increased
15%
Neck pain
15%
Peripheral sensory neuropathy
13%
Infections and infestations - Other
13%
Diarrhea
13%
Dysgeusia
13%
Rash acneiform
13%
Rash maculo-papular
10%
Arthralgia
10%
Neutrophil count decreased
10%
Dizziness
10%
Edema limbs
8%
Oral dysesthesia
8%
Anxiety
8%
Respiratory failure
8%
Pneumonitis
8%
Pruritus
8%
Facial pain
8%
Back pain
8%
Dry mouth
8%
Dry skin
8%
Hypertension
8%
INR increased
8%
Neck edema
5%
Allergic rhinitis
5%
Pleural effusion
5%
General disorders and administration site conditions - Other
5%
Hypernatremia
5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
5%
Skin infection
5%
Dyspepsia
5%
Ear pain
5%
Epistaxis
5%
Gastroesophageal reflux disease
5%
Generalized muscle weakness
5%
Hypomagnesemia
5%
Leukocytosis
5%
Lung infection
5%
Lymphedema
5%
Sore throat
5%
Tumor pain
5%
Urinary frequency
5%
Hearing impaired
5%
Sinusitis
5%
Chills
5%
Dehydration
5%
Hypercalcemia
5%
Hyperkalemia
5%
Myalgia
5%
Papulopustular rash
3%
Alopecia
3%
Vertigo
3%
Tracheostomy site bleeding
3%
Oral pain
3%
Pharyngeal hemorrhage
3%
Laryngeal obstruction
3%
Anorectal infection
3%
Hypoxia
3%
Pleural infection
3%
Pleuritic pain
3%
Pneumothorax
3%
Respiratory, thoracic and mediastinal disorders - Other
3%
Stridor
3%
Postnasal drip
3%
Skin and subcutaneous tissue disorders - Other
3%
Skin ulceration
3%
Eye disorders - Other
3%
Heart failure
3%
Tracheal hemorrhage
3%
Blurred vision
3%
Hypotension
3%
Palmar-plantar erythrodysesthesia syndrome
3%
Peripheral motor neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Temsirolimus)
Arm A (Cetuximab and Temsirolimus)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single infusion of TemsirolimusExperimental Treatment1 Intervention
Single infusion of Temsirolimus via super-selective intra-arterial infusion or IV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temsirolimus
2008
Completed Phase 2
~1940

Find a Location

Who is running the clinical trial?

Nader SanaiLead Sponsor
8 Previous Clinical Trials
316 Total Patients Enrolled
Barrow Neurological InstituteOTHER
26 Previous Clinical Trials
7,023 Total Patients Enrolled
Ivy Brain Tumor CenterOTHER
11 Previous Clinical Trials
827 Total Patients Enrolled
Nader Sanai, MDPrincipal InvestigatorChief Scientific Officer/Director
13 Previous Clinical Trials
1,007 Total Patients Enrolled

Media Library

Temsirolimus (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05773326 — Phase < 1
Solid Tumors Research Study Groups: Single infusion of Temsirolimus
Solid Tumors Clinical Trial 2023: Temsirolimus Highlights & Side Effects. Trial Name: NCT05773326 — Phase < 1
Temsirolimus (mTOR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05773326 — Phase < 1
~2 spots leftby Apr 2025
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