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Phase II Trial Evaluating Gleevec® (imatinib mesilate formerly known as STI571) in Patients with Anaplastic Thyroid Carcinoma

This study will examine an investigational (experimental) treatment Gleevec® (imatinib mesilate formerly known as STI571). Gleevec® is approved for the treatment of patients with chronic myeloid leukemia (CML) and for the treatment of patients with gastrointestinal stromal tumors (GIST). It is considered experimental for the treatment of thyroid cancer, and how well this drug will work in thyroid cancer is not known. The hope is that it will put cancer into remission.

Taking part in this study is completely voluntary. You do not have to participate if you don't want to. You may also leave the study at any time. If you leave the study before it is finished, there will be no penalty to you, and you will not lose any benefits to which you are otherwise entitled.

Who can take part in this study?

Patients 18 years of age or older who have been diagnosed with a type of thyroid cancer called anaplastic thyroid cancer that has spread to the point where it is no longer curable by surgery or radiation.

Women who are pregnant or nursing a child may not participate in this trial. You must confirm that to the best of your knowledge, you are not now pregnant, and that you do not intend to become pregnant during the trial. If you suspect that you have become pregnant during the trial, you must notify the Study Doctor immediately. If you are pregnant you will be withdrawn from the trial without your consent. Men and women are to use birth control for the duration of the trial and for at least 6 months after the last dose of Gleevec®.

You must meet all of the eligibility requirements for this study as outlined in the study protocol and confirmed by your physician.

What exactly will be done to me in this study? What kinds of research procedures will I receive if I agree to take part in this study?

Prior to entering this study, you must sign this consent form. You will be evaluated prior to being enrolled in this study to make sure that you meet the eligibility requirements for participation. The prestudy evaluations include a medical history, physical examination, blood laboratory evaluations, and special x-rays called CT scans to evaluate the extent of your disease.

If you decide to participate in this study, you will be treated as an outpatient with Gleevec® 100 mg tablets. The strength of each tablet is 100 mg. Initially, you will take 4 tablets (400 mg) twice a day, once in the morning and once in the evening. Your dosage may be adjusted if you experience side effects. The length of your treatment will depend on your tumor’s response to Gleevec®, which will be determined by x-ray studies. If your tumor shrinks in size after 8 weeks of Gleevec®, you will then continue therapy. If your tumor grows, you will be taken off of the study.

Gleevec® is a local irritant and must be taken in the sitting position with a large glass (250 mL) of water. Doses of Gleevec® should be taken with food but you should try to avoid foods or beverages containing caffeine, oranges/orange juices, or milk at the time of dosing. Gleevec® should not be taken with grapefruit juice.

You will have blood drawn (approximately 1-2 tablespoons) prior to your first dose of Gleevec®, and then on weeks 1, 2, 3, 4, 6, 8, 12, and 16 for laboratory testing. After the initial 16 weeks, blood will be drawn every 4 weeks.

MRI and/or CT scans will be done prior to entering the study and at week 8 and 16. After the initial 16 weeks, MRI and/or CT scans will be done every 3 months.

There are circumstances under which your doctor might be required to discontinue your treatment whether you agree or not. These circumstances include: your tumor gets worse despite the treatment; side effects of the treatment are too dangerous for you; new information about the drug becomes available and this information suggests the drug will be ineffective or unsafe for you.

How much of my time will be needed to take part in this study? When will my participation in the study be over?

In order to participate in this study, you will have to be seen at the University of Michigan in the medical oncology clinic before receiving the drug and every four weeks thereafter up to 16 weeks while on Gleevec®. These visits, which include laboratory blood draws, may take up to one to three hours. If your tumor continues to shrink while on Gleevec® after 16 weeks of treatment, you will continue to be seen in the medical oncology clinic regularly. Your physician will determine, at that time, how often you will need to be seen. Your participation in the study will end if your cancer does not respond to Gleevec® after 16 weeks. As mentioned above, if your cancer is responding to Gleevec®, you will continue on this medication indefinitely or until your cancer starts to grow (while taking Gleevec®).

What risks will I face by taking part in the study? What will the researchers do to protect me against these risks?

You will be kept fully informed of any events that occur during the course of the trial which might affect your safety.

Common side effects that can occur during treatment with Gleevec® are headache, nausea, vomiting, diarrhea, indigestion, skin rash, fever, muscle cramps, pain in the muscles, joints, limbs and bones, and swelling of the limbs, face and periorbital region (around eyes).

Other possible side effects of Gleevec® are loss of appetite, dizziness, taste disturbance, numbness of the hands or feet, insomnia, irritated eyes (conjunctivitis), increased tear production, drooping of the upper eyelid caused by muscle paralysis and weakness (ptosis), abdominal pain or gas, constipation, accumulation of urine in the kidney because of an obstruction in the ureter (tube that carries urine from the kidney to the bladder), dry mouth, itching, reddening of the skin, dry skin, cough, shortness of breath, petechia (purplish red spot on the skin) hair loss or thinning, night sweats, fatigue, weakness, increased muscle tension, and increased weight.

Gleevec® is sometimes associated with stomach irritation, thus it should be taken with the largest meal of the day and with a large glass of water to lessen this problem. It is suggested that a minimum of 1 hour be allowed between the last pills and going to bed.

Laboratory abnormalities observed in some patients required temporarily interrupting the study drug, or reducing the dose. The laboratory abnormalities included elevated liver or renal (kidney) function tests, low platelet or white blood cell or red blood cell counts and disturbances in electrolyte (chemicals found in the blood, e.g. sodium, potassium, magnesium) balance. Lowering of your white blood cell count could lead to an increased risk of infection. Lowering of your platelet count could lead to an increased risk of bleeding (hemorrhage). Lowering of your red blood cells can lead to fatigue. If you should develop a fever when your white blood count is low, you may need to be hospitalized to receive treatment. Transfusions may be required to counteract the effects of a low platelet count or low red blood cells. Elevated liver tests can indicate liver damage. Elevated renal tests can indicate kidney damage. Your laboratory values will be monitored closely and the dose of your medication will be adjusted if your blood tests are abnormal. It is expected that these effects may be reversed by decreasing the dose of the drug, or by temporarily stopping the study drug.

Gleevec® is often associated with swelling and occasionally marked fluid retention. Some patients have reported a rapid gain in body weight. Other patients have developed pleural effusions (fluid around lungs) and/or ascites (swollen abdomen), or pulmonary edema (fluid in the lungs), or pericardial effusions (fluid in the sac that surrounds the heart). A minority have developed signs of congestive heart failure. Therefore, you are asked to closely monitor your body weight twice a week and report to your doctor any rapid increase greater than 2 kg (or 5 pounds). (If this happens, a check-up including physical examination, blood tests and X-rays will be performed as required by your condition.)

One patient taking Gleevec® who had no known history of liver problems has died on study due to liver failure. The patient was also taking acetaminophen (Tylenol®). It is recommended to adhere carefully to the instructions and warnings included in the acetaminophen package and if possible restrict your use.

Because some over the counter and prescription medication can reduce the effectiveness or enhance the side effects of Gleevec® and/or Gleevec® can increase the side effects or lessen the effectiveness of some medication, it is recommended that you review all over-the-counter, health food supplements and prescription medications that you are taking with your physician prior to taking them. In addition, you must not regularly drink grapefruit juice or eat grapefruit sections while taking Gleevec.

Gastrointestinal (stomach, bowel) bleeding and CNS (brain) hemorrhages have been reported in a minority of patients. Occasional chest pains have been experienced. There have been rare reports of ruptured spleen, multi-organ failure, sepsis (blood infection), septic shock (with very low blood pressure and organ damage), respiratory failure (failure of the lungs to function properly), low blood pressure, dehydration, renal failure (the inability of the kidneys to excrete wastes, concentrate urine and maintain electrolyte balance), inflammation (pain, tenderness) of the pancreas; which can make the pancreas stop working properly, and pneumonia.

In animal studies, rats given Gleevec® had a higher incidence of tumors of the urinary and genital organs than rats not given Gleevec®. Preliminary analysis of safety data from previous clinical trials does not provide evidence for an overall incidence of malignancies in patients treated with Gleevec® compared to that of the general population.

These and other side effects may occur and could be severe or life threatening. Some of the symptoms listed above have led to death in a few patients. You will be closely monitored for any side effects and should report any changes in the way you feel to your doctor. You will be kept fully informed of any events that occur during the course of the trial which might affect your safety and change your decision to continue participation in this trial.

As with many cancer treatments, it is important that you do not become pregnant or father a child until your treatment has completely finished. The risks to an unborn human fetus or nursing a child from Gleevec® are not known. Women who are pregnant or nursing a child may not participate in this trial. You must confirm that to the best of your knowledge, you are not now pregnant, and that you do not intend to become pregnant during the trial. If you are of child bearing potential, the Study Doctor will discuss appropriate birth control measures with you. If you suspect that you have become pregnant during the trial, you must notify the Study Doctor immediately. If you are pregnant you will be withdrawn from the trial without your consent. Men and women are to use birth control for the duration of the trial and for 6 months after chemotherapy.

What happens if I get hurt, become sick, or have other problems as a result of this research?

The researchers have taken steps to minimize the known or expected risks. However, you may still experience problems or side effects, even when the researchers are careful to avoid them. If you believe that you have been harmed, notify the researchers listed in Section 10 of this form. The University of Michigan will provide first aid or emergency care. The cost of this first aid or emergency care may be billed to your insurance company, but if it is not covered by your insurance, the University of Michigan will pay for it. Additional medical care will be provided if the University determines that it is responsible to provide such treatment. If you sign this form, you do not give up your right to seek additional compensation if you are harmed as a result of being in this study.

Please note: It is important that you tell the researchers about any injuries, side effects, or other problems that you experience during this study. You may also need to tell your regular doctors.

If I take part in this study, can I also participate in other studies?

Being in more than one research study at the same time, or even at different times, may increase the risks to you. It may also affect the results of the studies. You should not take part in more than one study without approval from the researchers involved in each study.

How could I benefit if I take part in this study? How could others benefit?

You may not receive any personal benefits from being in this study.
It is hoped that by investigating the results of this study Gleevec®, the data collected may lead to improvement in the treatment of your thyroid cancer, if not for you, then for others with the same disease process.

Will the researchers tell me if they learn of new information that could change my willingness to stay in this study?

Yes, the researchers will tell you if they learn of important new information that may change your willingness to stay in this study. If new information is provided to you after you have joined the study, it is possible that you may be asked to sign a new consent form that includes the new information.

If I decide not to take part in this study, what other options do I have?
Treatment of thyroid cancer consists of thyroid removal if the tumor is confined to the local area. However, there is no generally accepted standard of care regarding the extent of surgery or post-surgical therapy, since the prognosis appears grim regardless. Radiation therapy with chemotherapy is used to decrease spreading of tumors. Various approaches with single agents and different combinations have failed to provide adequate control of thyroid cancer. To date, there remains no standard treatment for this cancer in the setting of metastatic disease. Doxorubicin has been most commonly used, even with disappointing results.

Another option is you might qualify for other investigational (research) studies besides this one. Your doctor will discuss these alternatives with you. If you decide not to participate in this study, it will not affect your future treatment.

If I want to stop participating in the study, what should I do?

You are free to leave the study at any time. If you leave the study before it is finished, there will be no penalty to you, and you will not lose any benefits to which you may otherwise be entitled. If you choose to tell the researchers why you are leaving the study, your reasons for leaving may be kept as part of the study record. If you decide to leave the study before it is finished, please notify one of the persons listed in Section 10 “Contact Information” (below).

Could there be any harm to me if I decide to leave the study before it is finished?

There are no dangers to you if you decide to leave the study early. If you remove yourself from the study at anytime and have contact with your study doctor you will undergo the Final Visit Examination. Described in section 4.

Could the researchers take me out of the study even if I want to continue to participate?

Yes. There are many reasons why the researchers may need to end your participation in the study. Some examples are:

Will taking part in this study cost me anything? Will I or my insurance company be billed for any costs of the study? If so, which costs? What happens if my insurance does not cover these costs?

Gleevec® is provided free of charge by Novartis Pharmaceuticals for a time span of one year (or so long as you remain on study) after which time you may only be able to continue Gleevec® at your own expense if alternative means of obtaining Gleevec® are not available.

Novartis will not provide payments for any medical expenses which you may incur as a result of your participation in this study. No other type of compensation will be provided by Novartis.

Clinic visits and laboratory or other tests, which are not being conducted for research purposes will not be free. These costs will be billed to you or your insurance carrier. How much you will have to pay depends on whether or not you have insurance and what cost your insurance covers. You will not be charged for any of the investigation-related laboratory tests (medical history and physical, pregnancy tests, tumor related imaging (MRI/CT scans), research related blood testing).

Will I be paid or given anything for taking part in this study?
No.

Who could profit or financially benefit from the study results?
The company whose product is being studied: Novartis

For more information, or to enroll in this study, please call Cancer AnswerLine at 800-865-1125.

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