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Anatomy of the Thymus Gland

The thymus, a small organ that lies in the upper chest under the breastbone, is part of the lymph system. It makes white blood cells, called lymphocytes, that protect the body against infections.

WHAT HAPPENS AFTER A CLINICAL TRIAL IS COMPLETED?

After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about further testing. After a phase I or II trial, the researchers decide whether to move on to the next phase or to stop testing the agent or intervention because it was unsafe or ineffective. When a phase III trial is completed, the researchers examine the data and decide whether the results have medical importance.

Results from clinical trials are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. If the results are particularly important, they may be featured in news media and discussed at scientific meetings and by patient advocacy groups before they are published. Once a new approach has been proven safe and effective in a clinical trial, it may become the standard of medical practice.

Ask the research team members if the study results have been or will be published. Published study results are also available by searching for the study's official name or Protocol ID number in the National Library of Medicine's PubMed® database.

WHAT QUESTIONS SHOULD I ASK IF OFFERED A CLINICAL TRIAL?

If you are offered a clinical trial, feel free to ask any questions or bring up any issues concerning the trial at any time. The following suggestions may give you some ideas as you think about your own questions.

The study

• What is the purpose of the study?
• Why do researchers think the approach may be effective?
• Who will fund the study?
• Who has reviewed and approved the study?
• How are study results and safety of participants being checked?
• How long will the study last?
• What will my responsibilities be if I participate?

Possible risks and benefits

• What are my possible short-term benefits?
• What are my possible long-term benefits?
• What are my short-term risks, such as side effects?
• What are my possible long-term risks?
• What other options do people with my disease have?
• How do the possible risks and benefits of this trial compare with those options?

Participation and care

• What kinds of therapies, procedures and /or tests will I have during the trial?
• Will they hurt, and if so, for how long?
• How do the tests in the study compare with those I would have outside of the trial?
• Will I be able to take my regular medications while in the clinical trial?
• Where will I have my medical care?
• Who will be in charge of my care?

Personal issues

• How could being in this study affect my daily life?
• Can I talk to other people in the study?

Cost issues

• Will I have to pay for any part of the trial such as tests or the study drug?
• If so, what will the charges likely be?
• What is my health insurance likely to cover?
• Who can help answer any questions from my insurance company or health plan?
• Will there be any travel or child care costs that I need to consider while I am in the trial?

Tips for asking your doctor about trials

• Consider taking a family member or friend along, for support and for help in asking questions or recording answers.
• Plan ahead what to ask — but don't hesitate to ask any new questions you think of while you're there.
• Write down your questions in advance, to make sure you remember to ask them all.
• Write down the answers, so that you can review them whenever you want.
• Ask about bringing a tape recorder to make a taped record of what's said (even if you write down answers).

This information courtesy of Cancer.gov.

WHAT DO I NEED TO KNOW IF I AM THINKING ABOUT PARTICIPATING?

Risks and benefits

Clinical trials involve risks, just as routine medical care and the activities of daily living. When weighing the risks of research, you can consider two important factors:

1. the degree of harm that could result from participating in the study, and
2. the chance of any harm occurring.

Most clinical studies pose the risk of minor discomfort, which lasts only a short time. However, some study participants experience complications that require medical attention. In rare cases, participants have been seriously injured or have died of complications resulting from their participation in trials of experimental therapies. The specific risks associated with a research protocol are described in detail in the informed consent document, which participants are asked to sign before participating in research. Also, a member of the research team explains the major risks of participating in a study and will answer any questions you have about the study. Before deciding to participate, carefully consider possible risks and benefits.

Potential benefits

Well-designed and well-executed clinical trials provide the best approach for participants to:

• Play an active role in their health care.
• Gain access to new research treatments before they are widely available.
• Receive regular and careful medical attention from a research team that includes doctors and other health professionals.
• Help others by contributing to medical research.

Potential risks

Risks to participating in clinical trials include the following:

• There may be unpleasant, serious, or even life-threatening side effects to experimental treatment.
• The study may require more time and attention than standard treatment would, including visits to the study site, more blood tests, more treatments, hospital stays, or complex dosage requirements.

Why Should I Participate in a Clinical Trial?

Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease.
Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments.
The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.
People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.
Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.





http://www.nih.gov/health/clinicaltrials/

Clinical Trials to Treat Thymoma and Thymic Carcinoma

A Phase 1/2 Study of PXD101 (Belinostat) in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Advanced or Recurrent Thymic, Malignancies

Trial Description
Summary

Background:

• Tumors of the thymus are rare and can be treated with surgery, but it is often difficult to determine whether a thymic tumor is malignant based on biopsy alone and the long-term survival rate is less than 50 percent. Because thymic tumors are so rare, most treatment knowledge comes from a relatively small series of cases, and the choice of treatment usually depends on the hospital or clinic staff's experience and familiarity with a given chemotherapy and surgery regimen.

• Belinostat is an investigational anticancer drug that has not yet been approved by the Food and Drug Administration for use in any cancer. Researchers are interested in determining whether belinostat can be combined with conventional chemotherapy to safely and effectively treat advanced thymic cancer.

Objectives:

• To determine a safe and tolerable dose of belinostat that can be given in combination with cisplatin, doxorubicin, and cyclophosphamide.

• To determine if belinostat (combined with the abovementioned standard chemotherapy regimen) is effective against thymic cancer cells.

Eligibility:

• Individuals at least 18 years of age who have been diagnosed with advanced or recurrent thymic malignancy that is not considered to be curable with surgery or radiation therapy, and who have not received previous chemotherapy treatment.

Design:

• Participants will be screened with a physical exam, blood tests, and imaging studies as directed by the study researchers.
•  
• Participants will receive six 21-day cycles (18 weeks) of treatment with belinostat in combination with cisplatin, doxorubicin, and cyclophosphamide. The treatment will require continuous infusion over 3 days, and participants will remain in the treatment center during this time. Participants will have regular blood tests, clinic visits, and imaging studies during the treatment period.

• Participants who complete the six treatment cycles with no severe side effects may be offered the option to continue treatment with belinostat alone.

• After the 18-week study period, participants will return for regular follow-up exams for at least 4 weeks, and will be asked to remain in contact with the study researchers once a year to continue to study long-term effects....

 Trial Contact Information
Trial Lead Organizations/Sponsors
National Cancer Institute

Arun Rajan, M.D.

Principal Investigator

Michell J Manu, R.N.		Ph: (301) 402-4423
		Email: manumichell@mail.nih.gov

Trial Sites

U.S.A.
Maryland
	Bethesda
	NIH - Warren Grant Magnuson Clinical Center
		For more information at the NIH Clinical Center contact National Cancer Institute Referral Office	Ph: (888) NCI-1937
Massachusetts
	Boston
	Massachusetts General Hospital

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01100944
Information obtained from ClinicalTrials.gov on February 18, 2013

Recurrent Thymoma and Thymic Carcinoma

Recurrent thymoma and thymic carcinoma is cancer that has recurred (come back) after it has been treated. The cancer may come back in the thymus or in other parts of the body. Thymic carcinomas commonly recur. Thymomas may recur after a long time. There is also an increased risk of having another type of cancer after having a thymoma. For these reasons, lifelong follow-up is needed.

Recurrent Thymoma and Thymic Carcinoma

Treatment of recurrent thymoma and thymic carcinoma may include the following:

• Surgery with or without radiation therapy.
• Radiation therapy
• Hormone therapy
• A clinical trial of chemotherapy using one or more anticancer drugs.
• A clinical trial of other new treatments

Stages of Thymoma and Thymic Carcinoma

Tests done to detect thymoma or thymic carcinoma are also used to stage the disease.
Staging is the process used to find out if cancer has spread from the thymus to other parts of the body. The findings made during surgery and the results of tests and procedures are used to determine the stage of the disease. It is important to know the stage in order to plan treatment.

There are three ways that cancer spreads in the body.

The three ways that cancer spreads in the body are:

• Through tissue. Cancer invades the surrounding normal tissue.
• Through the lymph system. Cancer invades the lymph system and travels through the lymph vessels to other places in the body.
• Through the blood. Cancer invades the veins and capillaries and travels through the blood to other places in the body.

When cancer cells break away from the primary (original) tumor and travel through the lymph or blood to other places in the body, another (secondary) tumor may form. This process is called metastasis. The secondary (metastatic) tumor is the same type of cancer as the primary tumor. For example, if breast cancer spreads to the bones, the cancer cells in the bones are actually breast cancer cells. The disease is metastatic breast cancer, not bone cancer.
The following stages are used for thymoma:
Noninvasive thymoma (stage I)
In stage I, cancer is found only within the thymus. All cancer cells are inside the capsule (sac) that surrounds the thymus.
Invasive thymoma (stage II, stage III, and stage IV)
Invasive thymoma includes stage II, stage III, and stage IV.
In stage II, cancer has spread through the capsule and into the fat around the thymus or into the lining of the chest cavity.
In stage III, cancer has spread to nearby organs in the chest, including the lung, the sac around the heart, or large blood vessels that carry blood to the heart.
Stage IV is divided into stage IVA and stage IVB, depending on where the cancer has spread.

• In stage IVA, cancer has spread widely around the lungs and heart.
• In stage IVB, cancer has spread to the blood or lymph system.

Thymic carcinomas have usually spread to other parts of the body when diagnosed.

The staging system used for thymomas is sometimes used for thymic carcinomas.

Treatment Options for Thymoma and Thymic Carcinoma

Noninvasive Thymoma and Thymic Carcinoma

Treatment of noninvasive thymoma and thymic carcinoma may include the following:

• Surgery to remove the tumor.
• Radiation therapy.

Invasive Thymoma and Thymic Carcinoma

Treatment of invasive thymoma and thymic carcinoma that may be completely removed by surgery includes the following:

• Surgery followed by radiation therapy.
• A clinical trial of other new treatments.

Treatment of invasive thymoma and thymic carcinoma that cannot be removed completely by surgery includes the following:

• Surgery to remove part of the tumor, followed by radiation therapy with or without chemotherapy.
• A clinical trial of chemotherapy using one or more anticancer drugs.
• A clinical trial of chemotherapy before surgery, with or without radiation therapy.
• A clinical trial of combination chemotherapy followed by radiation therapy.
• A clinical trial of other new treatments.

Thymoma and Thymic Carcinoma

(Also Called 'Malignant Thymoma', 'Thymus Cancer')

Thymoma and thymic carcinoma are diseases in which malignant (cancer) cells form on the outside surface of the thymus.
The thymus, a small organ that lies in the upper chest under the breastbone, is part of the lymph system. It makes white blood cells, called lymphocytes, that protect the body against infections.
There are different types of tumors of the thymus. Thymomas and thymic carcinomas are rare tumors of the cells that are on the outside surface of the thymus. The tumor cells in a thymoma look similar to the normal cells of the thymus, grow slowly, and rarely spread beyond the thymus. On the other hand, the tumor cells in a thymic carcinoma look very different from the normal cells of the thymus, grow more quickly, and have usually spread to other parts of the body when the cancer is found. Thymic carcinoma is more difficult to treat than thymoma.

Having a disease called myasthenia gravis can affect the risk of developing thymoma.

People with thymoma often have other diseases as well. These diseases may include myasthenia gravis, polymyositis, lupus erythematosus, rheumatoid arthritis, thyroiditis, Sjögren syndrome, and hypogammaglobulinemia.

Possible signs of thymoma and thymic carcinoma include a cough and chest pain.

Sometimes thymoma and thymic carcinoma do not cause symptoms. The cancer may be found during a routine chest x-ray. The following symptoms may be caused by thymoma, thymic carcinoma, or other conditions. A doctor should be consulted if any of the following problems occur:

• A cough that doesn't go away.
• Chest pain.
• Trouble breathing.