Sunitinib Plus Temsirolimus in Patients With Renal Cell Cancer (RCC)

2014-08-27 03:13:45 | BioPortfolio


The goal of this clinical research study is to find the highest tolerable dose of the combination of sunitinib and temsirolimus that can be given to patients with metastatic kidney cancer.


The Study Drugs:

Sunitinib is designed to block pathways that control important events (such as the growth of blood vessels) that are essential for the growth of cancer.

Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to die.

Screening Tests:

Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed within 4 weeks before you can begin receiving the study drugs:

- You will have computed tomography (CT) scans of your chest and abdomen and/or a magnetic resonance imaging (MRI) scan of your abdomen to check the status of the disease.

- You will have an MRI scan and/or a CT scan of your brain to check the status of the disease.

- You will have an echocardiogram or a multi-gated acquisition (MUGA) scan to check your heart's health.

The following tests and procedures will be performed within 1 week before you can begin receiving the study drugs:

- Your complete medical history will be recorded, including any drugs you may be taking.

- You will have a physical exam, including measurement of your height, weight, and vital signs (blood pressure, breathing rate, heart rate, and temperature.

- You will be asked how well you are able to perform the normal activities of daily living (performance status).

- Blood (about 3 teaspoons) and urine will be collected for routine tests. This blood will also be used to check your thyroid function and it will include a pregnancy test for women who are able to have children. To take part in this study, the pregnancy test must be negative.

The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other options will be discussed with you.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of the combination of sunitinib and temsirolimus based on when you joined this study. There will be 2 stages in this study.

Up to 5 dose levels of the study drug combination will be tested in Stage 1. Two (2) participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.

During Stage 2, different doses of the individual study drugs will be tested based on the highest tolerable combination dose that was found in Stage 1.

Study Drug Administration:

During each 3-week "study cycle," you will take sunitinib 1 time each day (either with or without food) for 2 weeks followed by 1 week of rest with no study drug.

You will receive temsirolimus by vein 1 time every week over 30-60 minutes. About 30 minutes before you receive temsirolimus, you will receive Benadryl (diphenhydramine) by vein over 30 minutes to help prevent side effects.

If you have any side effects from any of the drugs, tell the study doctor right away. The study doctor may then lower the dose or keep the dose level the same.

Study Visits:

Every week (right before you receive temsirolimus), blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of every cycle:

- You will have a physical exam, including measurement of your vital signs.

- You will be asked about any drugs or treatments you may be receiving.

- Your performance status will be recorded.

- Blood (about 2 teaspoons) will be drawn for routine tests (in addition to the weekly blood draw described above).

On Day 1 of Cycle 3:

Blood (about 2 teaspoons) will be drawn to check your thyroid function. Urine will be collected for routine tests.

Every 6 weeks, you will have the same imaging scans (CT and/or MRI scan) that you had at the screening visit.

Blood Pressure Monitoring:

During the first 4 weeks of the study, your blood pressure will be checked weekly. This may be done at your local doctor's office. You should write down your blood pressure each time it is checked in a blood pressure journal that the study staff will give you and bring it with you when you see your doctor.

Length of Study:

You will remain on study for as long as you are benefiting. You will be taken off study if the disease gets worse or if you have intolerable side effects.

End-of-Study Visit:

After the last dose of study drug, you will have an end-of-study visit. At the end-of-study visit, the following tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs.

- You will be asked about any drugs or treatments you may be receiving.

- You will be asked about any side effects you may have experienced since your last visit.

This is an investigational study. Sunitinib and temsirolimus are both FDA approved and commercially available for the treatment of advanced kidney cancer. The use of the drugs in combination is investigational.

Up to 60 patients will take part in this study. All will be enrolled at M.D. Anderson.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Renal Cell Cancer


Sunitinib, Temsirolimus


UT MD Anderson Cancer Center
United States




M.D. Anderson Cancer Center

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:13:45-0400

Clinical Trials [3899 Associated Clinical Trials listed on BioPortfolio]

Study in Non-Clear Cell Renal Carcinoma (Ncc-RCC) Temsirolimus Versus Sunitinib

This will be a prospective, open-label, randomized multicenter phase-II study to evaluate progression free survival (PFS) in patients with locally advanced or metastatic non-clear cell ren...

Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]

The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced...

Evaluation of a Promising New Combination of Protein Kinase Inhibitors on Organotypic Cultures of Human Renal Tumors

The investigators objective is to test the combination directly on organotypic cultures of tumors from patients after their excision in the Department of Urology and Renal Transplantation ...

Combination of Temsirolimus and Bevacizumab in Patient With Metastatic Renal Cell Carcinoma

The TORAVA trial is designed to evaluate the progression-free rate at 48 weeks of a combination of Torisel® and Avastin® given at first-line treatment in patients with metastatic renal c...

Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer

The goal of this clinical research study is to learn the effectiveness of Sutent® (sunitinib malate, SU011248) in the treatment of patients with non-clear cell renal cell cancer. The safe...

PubMed Articles [28068 Associated PubMed Articles listed on BioPortfolio]

NT5E inhibition suppresses the growth of sunitinib-resistant cells and EMT course and AKT/GSK-3β signaling pathway in renal cell cancer.

We aimed to explore the mechanisms of sunitinib-resistance in renal cell cancer (RCC) and provide new therapeutic evidence and biomarkers for RCC treatment using human clear-cell renal cell carcinoma ...

RCAN1.4 acts as a suppressor of cancer progression and sunitinib resistance in clear cell renal cell carcinoma.

Clear cell renal cell carcinoma (ccRCC) is one of the most common malignant tumors in the urinary system, and its incidence continues to increase. Regulator of calcineurin 1 (RCAN1), one of the genes ...

Relationships between sunitinib plasma concentration and clinical outcomes in Japanese patients with metastatic renal cell carcinoma.

The aim was to investigate the relationships between total sunitinib plasma concentrations (sunitinib plus its active metabolite; N-desethyl sunitinib) and clinical outcomes in Japanese patients with ...

Development of a validated LC-MS/MS method for the in vitro and in vivo quantitation of sunitinib in glioblastoma cells and cancer patients.

Sunitinib is a multi-targeted tyrosine kinase inhibitor approved for the treatment of renal cell carcinoma and imatinib-resistant gastrointestinal stromal tumor and is currently being investigated aga...

Candidate MicroRNA Biomarkers of Therapeutic Response to Sunitinib in Metastatic Renal Cell Carcinoma: A Validation Study in Patients with Extremely Good and Poor Response.

Targeted therapy with the tyrosine kinase inhibitor sunitinib is used in the first line of metastatic renal cell carcinoma (mRCC) treatment. The aim of the present study was independent validation of ...

Medical and Biotech [MESH] Definitions

The amount of PLASMA that perfuses the KIDNEYS per unit time, approximately 10% greater than effective renal plasma flow (RENAL PLASMA FLOW, EFFECTIVE). It should be differentiated from the RENAL BLOOD FLOW; (RBF), which refers to the total volume of BLOOD flowing through the renal vasculature, while the renal plasma flow refers to the rate of plasma flow (RPF).

An autosomal dominant disorder caused by mutations in a tumor suppressor gene. This syndrome is characterized by abnormal growth of small blood vessels leading to a host of neoplasms. They include HEMANGIOBLASTOMA in the RETINA; CEREBELLUM; and SPINAL CORD; PHEOCHROMOCYTOMA; pancreatic tumors; and renal cell carcinoma (see CARCINOMA, RENAL CELL). Common clinical signs include HYPERTENSION and neurological dysfunctions.

Persistent high BLOOD PRESSURE due to KIDNEY DISEASES, such as those involving the renal parenchyma, the renal vasculature, or tumors that secrete RENIN.

Tumor suppressor genes located in the 18q21-qter region of human chromosome 18. The absence of these genes is associated with the formation of colorectal cancer (DCC stands for deleted in colorectal cancer). The products of these genes show significant homology to neural cell adhesion molecules and other related cell surface glycoproteins.

Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE. The most severe form is KIDNEY FAILURE. Renal function may deteriorate slowly (RENAL INSUFFICIENCY, CHRONIC) or precipitously (RENAL INSUFFICIENCY, ACUTE).

More From BioPortfolio on "Sunitinib Plus Temsirolimus in Patients With Renal Cell Cancer (RCC)"

Quick Search


Relevant Topics

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...

  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Searches Linking to this Trial