#1 Clinical Trials Search in Europe

Temsirolimus

Temsirolimus, also known by its brand name Torisel, is a drug being studied in various clinical trials for its potential in treating different types of cancer. This article explores the use of temsirolimus in clinical trials, focusing on its efficacy, safety, and application in treating conditions such as renal cell carcinoma, mantle cell lymphoma, and other advanced cancers. The trials aim to evaluate the drug’s effectiveness, determine optimal dosing, and assess its impact on patients’ quality of life and survival rates.

Table of Contents

What is Temsirolimus?

Temsirolimus is a medication used in cancer treatment. It’s also known by its brand name Torisel and other names like CCI-779 or cell cycle inhibitor 779[1][2]. This drug is primarily used to treat advanced kidney cancer, but researchers are studying its potential benefits for other types of cancer as well[3].

How Does Temsirolimus Work?

Temsirolimus belongs to a class of drugs called mTOR inhibitors. mTOR stands for “mammalian target of rapamycin,” which is a protein in our bodies that helps control cell growth. In cancer, this protein can become overactive, leading to uncontrolled cell growth. Temsirolimus works by blocking the activity of mTOR, which may help slow down or stop the growth of cancer cells[4].

Conditions Treated with Temsirolimus

While Temsirolimus is FDA-approved for treating advanced renal cell carcinoma (a type of kidney cancer), clinical trials are exploring its use in various other conditions, including:

  • Mantle Cell Lymphoma (MCL): A rare type of non-Hodgkin’s lymphoma[2]
  • Metastatic HER2-amplified or Triple Negative Breast Cancer: Advanced forms of breast cancer[4]
  • Gastrointestinal Stromal Tumors (GIST): A type of tumor that occurs in the digestive system[5]
  • Advanced Solid Tumors: Various types of cancers that form solid masses[6]
  • Pediatric Solid Tumors: Including neuroblastoma, rhabdomyosarcoma, and high-grade gliomas in children[7]
  • Prostate Cancer: Specifically in patients with castration-resistant prostate cancer[8]

How is Temsirolimus Administered?

Temsirolimus is typically given as an intravenous (IV) infusion, which means it’s delivered directly into your bloodstream through a vein. The usual dosage and schedule may vary depending on the specific condition being treated and individual patient factors. However, common administration patterns include:

  • Weekly infusions, often given over 30-60 minutes[1]
  • A typical adult dose of 25 mg once weekly[3]
  • In some cases, treatment may be given in cycles, with each cycle lasting about 3-4 weeks[4]

Your healthcare team will determine the most appropriate dosage and schedule for your specific situation.

Potential Side Effects

Like all medications, Temsirolimus can cause side effects. Some of the most commonly reported side effects include:

  • Fatigue: Feeling very tired or weak
  • Rash: Skin irritation or outbreak
  • Nausea and vomiting: Feeling sick to your stomach or throwing up
  • Mouth sores: Painful ulcers in the mouth
  • Loss of appetite: Not feeling hungry
  • Diarrhea: Loose, watery stools
  • Increased blood sugar levels: Which may lead to or worsen diabetes
  • Changes in blood cell counts: Which can increase the risk of infection or bleeding

Your healthcare team will monitor you closely for these and other potential side effects. It’s important to report any new symptoms or changes in your health to your doctor promptly[5][6].

Ongoing Clinical Trials

Researchers are continually studying Temsirolimus to better understand its effects and explore its potential in treating various types of cancer. Some areas of ongoing research include:

  • Combining Temsirolimus with other cancer treatments to potentially enhance effectiveness[4]
  • Studying the drug’s effects in different types of cancer, including rare and pediatric cancers[7]
  • Investigating the optimal dosing and administration schedules for different conditions[8]
  • Exploring biomarkers that might help predict which patients will respond best to the treatment[6]

If you’re interested in participating in a clinical trial involving Temsirolimus, talk to your oncologist about potential opportunities that might be suitable for your situation.

Aspect Details
Drug Name Temsirolimus (Torisel)
Mechanism of Action Kinase inhibitor targeting mTOR pathway
Cancer Types Studied Renal cell carcinoma, mantle cell lymphoma, prostate cancer, hepatocellular carcinoma, high-grade gliomas
Administration Intravenous infusion, typically 25 mg weekly
Common Side Effects Fatigue, rash, nausea, changes in blood cell counts
Primary Outcomes Overall response rate, progression-free survival, safety profile
Secondary Outcomes Overall survival, duration of response, pharmacokinetics, pharmacodynamics
Special Populations Studies include pediatric patients and specific ethnic groups (e.g., Japanese patients)
Ongoing Research Optimal dosing, combination therapies, biomarker studies (e.g., stathmin expression)

FAQ

  • What is temsirolimus and how does it work? Temsirolimus is a kinase inhibitor that blocks the growth of cancer cells by targeting the mTOR pathway. It is designed to interfere with cancer cell growth and potentially cause cancer cells to die.
  • What types of cancer is temsirolimus being studied for? Temsirolimus is being studied for various types of cancer, including advanced renal cell carcinoma, mantle cell lymphoma, prostate cancer, hepatocellular carcinoma, and high-grade gliomas.
  • How is temsirolimus administered in clinical trials? In most trials, temsirolimus is administered intravenously (through a vein) as an infusion. The typical dosage is 25 mg given once weekly, though some trials explore different dosing schedules or amounts.
  • What are some common side effects of temsirolimus? Common side effects observed in clinical trials include fatigue, rash, nausea, and changes in blood cell counts. Some trials also report monitoring for specific side effects such as interstitial lung disease and infection-related events.
  • How long do patients typically receive temsirolimus in clinical trials? The duration of treatment varies depending on the specific trial design. Some studies administer temsirolimus until disease progression or unacceptable toxicity, while others have fixed treatment periods. Follow-up periods can range from several months to several years.

Ongoing Clinical Trials on Temsirolimus

  • Study of Crizotinib and Temsirolimus for Children with ALK, ROS1, or MET Positive Cancers, Including Neuroblastoma and Rhabdomyosarcoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Finland France Germany Italy The Netherlands +3

Glossary

  • Temsirolimus: A kinase inhibitor drug designed to block the growth of cancer cells by targeting the mTOR pathway. It is also known by the brand name Torisel.
  • mTOR: Mammalian Target of Rapamycin, a protein that regulates cell growth and division. It is a target for cancer therapies like temsirolimus.
  • Renal Cell Carcinoma: A type of kidney cancer that starts in the lining of very small tubes in the kidney.
  • Mantle Cell Lymphoma: A rare type of non-Hodgkin lymphoma that affects white blood cells called B lymphocytes.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Pharmacodynamics: The study of the biochemical and physiological effects of drugs on the body, including their mechanisms of action.
  • RECIST Criteria: Response Evaluation Criteria In Solid Tumors, a set of rules used to assess how well a cancer patient responds to treatment.
  • Progression-Free Survival: The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall Survival: The length of time from either the date of diagnosis or the start of treatment that patients are still alive.
  • Dose-Limiting Toxicity: Side effects of a drug that are severe enough to prevent an increase in dose or require a decrease in dose.
  • Maximum Tolerated Dose: The highest dose of a drug that does not cause unacceptable side effects.
  • Interstitial Lung Disease: A group of disorders that cause inflammation and scarring of the lung tissue, which can be a potential side effect of some cancer treatments.

References

  1. https://clinicaltrials.gov/study/NCT01166126
  2. https://clinicaltrials.gov/study/NCT01180049
  3. https://clinicaltrials.gov/study/NCT01210482
  4. https://clinicaltrials.gov/study/NCT01111825
  5. https://clinicaltrials.gov/study/NCT00700258
  6. https://clinicaltrials.gov/study/NCT00877773
  7. https://clinicaltrials.gov/study/NCT00106353
  8. https://clinicaltrials.gov/study/NCT00919035