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mTOR inhibitor

Vorinostat + Temsirolimus for Brain Tumors

Phase 1

Waitlist Available

Led By Soumen Khatua

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 3 half-lives must have elapsed after treatment with a monoclonal antibody

Bilirubin < 1.5 x upper limit of normal (ULN) for age

Must not have

Patients who are currently receiving therapeutic anticoagulants are not eligible

Patients who are currently receiving ACE inhibitors are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of temsirolimus when given with vorinostat and with or without radiation therapy in treating younger patients with newly diagnosed or progressive diffuse intrinsic pontine glioma.

Who is the study for?

This trial is for young patients (6 months to 21 years old) with newly diagnosed or progressive diffuse intrinsic pontine glioma, a type of brain tumor. They should have no known curative therapy options and must have recovered from previous treatments. Patients need a certain level of physical ability, adequate organ function, and cannot be on certain medications like ACE inhibitors or anticoagulants.

What is being tested?

The trial is testing the combination of two drugs, Vorinostat and Temsirolimus, with or without radiation therapy to see how well they work against this type of brain tumor. The study aims to find the safest doses and observe side effects while assessing if these treatments can stop tumor growth by blocking enzymes needed for cell growth.

What are the potential side effects?

Possible side effects include reactions related to immune system suppression such as increased risk of infections, potential liver issues indicated by changes in blood tests, blood clotting problems that could affect bleeding times, as well as general symptoms like fatigue. Specific risks will also depend on whether radiation therapy is included.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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It has been long enough since my last monoclonal antibody treatment.

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My bilirubin levels are within the normal range for my age.

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My current cancer has no known cure or treatment to extend life with good quality.

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I am between 6 months and 21 years old.

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I am mostly able to care for myself and carry out daily activities.

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It has been over a week since my last non-antibody biologic treatment.

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My kidney function, measured by creatinine, is within the normal range for my age.

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My brain tumor diagnosis or progression is confirmed by a specific MRI scan.

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It has been over 6 weeks since my last immunotherapy treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently on blood thinners.

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I am not currently taking ACE inhibitors.

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I am not taking any immunosuppressive medications.

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I do not have any infections that are not responding to treatment.

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I have not been treated with specific therapies that would exclude me from certain study groups.

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I do not have any other types of cancer.

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I am not taking seizure medications that affect enzyme levels.

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I do not have a history of heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Maximum tolerated dose (MTD) of temsirolimus

Secondary study objectives

Radiographic response

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%

Insomnia

18%

Non-cardiac chest pain

18%

Aspartate aminotransferase increased

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%

Neutrophil count decreased

10%

Arthralgia

10%

Dizziness

10%

Edema limbs

Anxiety

Oral dysesthesia

Respiratory failure

Pneumonitis

Pruritus

Facial pain

Back pain

Dry mouth

Dry skin

Hypertension

INR increased

Neck edema

Allergic rhinitis

Pleural effusion

General disorders and administration site conditions - Other

Hypernatremia

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other

Skin infection

Dyspepsia

Ear pain

Epistaxis

Gastroesophageal reflux disease

Generalized muscle weakness

Hypomagnesemia

Leukocytosis

Lung infection

Lymphedema

Sore throat

Tumor pain

Urinary frequency

Hearing impaired

Sinusitis

Chills

Dehydration

Hypercalcemia

Hyperkalemia

Myalgia

Papulopustular rash

Vertigo

Oral pain

Alopecia

Tracheostomy site bleeding

Pharyngeal hemorrhage

Laryngeal obstruction

Anorectal infection

Hypoxia

Pleural infection

Pleuritic pain

Pneumothorax

Respiratory, thoracic and mediastinal disorders - Other

Stridor

Postnasal drip

Skin and subcutaneous tissue disorders - Other

Skin ulceration

Eye disorders - Other

Heart failure

Tracheal hemorrhage

Blurred vision

Hypotension

Palmar-plantar erythrodysesthesia syndrome

Peripheral motor neuropathy

100%

80%

60%

40%

20%

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

2Treatment groups

Experimental Treatment

Group I: Arm II (vorinostat, temsirolimus)Experimental Treatment2 Interventions

Patients receive vorinostat PO QD and temsirolimus IV over 30-90 minutes on days 1-8 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (vorinostat, radiation therapy, temsirolimus)Experimental Treatment3 Interventions

CHEMORADIOTHERAPY PHASE: Patients receive vorinostat QD and undergo radiation therapy QD for 30 fractions over 6-7 weeks. MAINTENANCE PHASE: Four to six weeks after the completion of radiation therapy, patients receive vorinostat PO QD and temsirolimus IV over 30-90 minutes on days 1-8 of each cycle. Treatment repeats every 28 days for 10 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Temsirolimus

2008

Completed Phase 2

~1940