Bevacizumab + Temsirolimus for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of bevacizumab and temsirolimus alone or in combination with valproic acid or cetuximab in treating patients with a malignancy that has spread to other places in the body or other disease that is not cancerous. Immunotherapy with bevacizumab and cetuximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as valproic acid, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bevacizumab and temsirolimus work better when given alone or with valproic acid or cetuximab in treating patients with a malignancy or other disease that is not cancerous.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it does require that you are not taking any other investigational or anticancer agents. If you are taking drugs that affect CYP3A4 enzymes, you may need to stop and wait for a certain period before starting the trial.
Is the combination of Bevacizumab and Temsirolimus safe for humans?
Bevacizumab, when used in combination with other treatments, has been generally well-tolerated in studies, with common side effects including high blood pressure, bleeding, and gastrointestinal issues. Cetuximab, another drug often used with Bevacizumab, can cause mild skin rashes and fatigue. While specific data on the combination of Bevacizumab and Temsirolimus is not provided, Bevacizumab's safety profile is well-documented in various cancer treatments.12345
What makes the drug combination of Bevacizumab, Cetuximab, Temsirolimus, and Valproic Acid unique for cancer treatment?
This drug combination is unique because it combines multiple agents that target different pathways in cancer cells, potentially enhancing treatment effectiveness. Bevacizumab and Cetuximab target blood vessel growth and cell growth signals, while Temsirolimus and Valproic Acid may enhance these effects by inhibiting cancer cell metabolism and growth.678910
What data supports the effectiveness of the drug combination Bevacizumab, Cetuximab, and Temsirolimus for cancer?
Research shows that Bevacizumab and Temsirolimus are active in treating advanced solid tumors, and Temsirolimus may help overcome resistance to Cetuximab and Bevacizumab. Additionally, Bevacizumab and Cetuximab are approved for treating metastatic colorectal cancer, improving survival and response rates.511121314
Who Is on the Research Team?
Sarina Piha-Paul, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults and children with advanced or metastatic cancer, or progressive benign diseases like LAM, NF type 2, Erdheim Chester disease. Participants must be in a certain health condition (Karnofsky >=60%, Lansky status >=60% for under 16s), not pregnant, using contraception, and have specific blood counts and organ function levels. They should not be on other cancer treatments or have had major surgery recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive temsirolimus, bevacizumab, and either valproic acid or cetuximab in a dose-escalation study to determine maximum tolerated doses and dose-limiting toxicities
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Preliminary assessment of anti-tumor efficacy and pharmacokinetic markers
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Cetuximab
- Temsirolimus
- Valproic Acid
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator