Germ Cell Tumors

Clinical Trials

Below is a list of Germ Cell Tumors clinical trials from the clinical trials database at Mayo Clinic.

This list includes only trials about which Mayo researchers choose to publish information. Mayo Clinic may be conducting other trials which are not in this database. Mayo's clinical trials include experimental treatments, often unavailable elsewhere, which frequently lead to improved patient care for people worldwide. Patients should ask their doctor at Mayo about clinical trials appropriate for their situation.

A Phase 3 Study of Reduced Therapy in the Treatment of Children with Low and Intermediate Risk Extracranial Germ Cell Tumors
This study is being done to:
- Avoid chemotherapy in low risk testicular/ovarian germ cell tumors by using surgery and observation, and using chemotherapy only if the tumor comes back.
- Lower the total amount of chemotherapy cycles given (three times instead of four)
for those patients getting chemotherapy and find out the effects, good and/or bad.
- Lower the number of days over which the chemotherapy is given from five to three days.
A secondary goal of the study is to understand the biology of germ cell tumors better.
Researchers would like to know more about the genetic factors that affects the development of germ cell tumors.
Patients are being asked to take part in this study because they have been told that they have a germ cell tumor. A germ cell tumor is a type of cancer that happens in the ovaries (for females) or the testes (for males). This tumor may also be found in other areas of the
body such as the brain, chest or abdomen.
A germ cell tumor is considered low risk when it is present only in the testes or ovaries and is completely taken out by surgery.
A germ cell tumor is considered intermediate risk when:
- It is present only in the testes or ovary, but is not completely taken out by surgery.
- It is present in the testes or ovary and has spread to the lymph nodes or other organs.
- It is present only at one site outside the ovaries or testes, but may or may not be completely taken out by surgery.
The term, risk, refers to the chance of the cancer coming back after treatment.

The standard treatment for patients who have low risk testicular tumors is surgery to take out the tumor and observation; the standard treatment for patients with low risk ovarian tumors is surgery plus chemotherapy (cancer-fighting drugs) given for four cycles (with five days for each cycle of treatment).
The standard treatment for patients with intermediate risk germ cell tumors is surgery plus chemotherapy given for four cycles (with five days for each cycle of treatment).
Germ cell tumors are rare, and account for only 3 percent of all childhood cancers. However, the survival rate for patients with these types of tumors is very high at 95 percent for low risk tumors and 93 percent for intermediate risk tumors.
The standard treatment for germ cell tumors is very effective. Study doctors would like to know if it is possible to lower the side effects from chemotherapy treatment. Side effects are unintended or unwanted results. When chemotherapy is lowered, there have been fewer side effects from chemotherapy. This study will test if lowering the amount of chemotherapy given to intermediate risk tumor patients and not giving chemotherapy to low risk patients will result in the same high survival rate.
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ACNS0232, Radiotherapy Alone vs. Chemotherapy Followed by Responsebased Radiotherapy for Newly Diagnosed Primary CNS (Central Nervous System) Germinoma
Patients are being asked to take part in this study because they have a type of cancer called a germinoma germ cell tumor, which can be a rapidly growing tumor able of spreading to other parts of the brain and spinal cord. Normal germ cells are the body's reproductive cells which are usually found in reproductive organs. Germ cells typically give rise to egg cells in ovaries of females and sperm cells in the testicles of males.
There are different types of germ cell tumors. Doctors find out which type a person has
based on the results of a biopsy (a surgical procedure that removes a portion of the tumor for testing) and/or tumor markers. Tumor markers are chemical substances (such as
proteins) that are produced by tumor cells and released into the bodily fluids. Germ cell tumors can be malignant and can sometimes spread through the brain and spinal canal before symptoms appear. The amount of radiation treatment patient's get, and the chance of cure, will depend on whether the disease has spread at the time the patient's diagnosis is made.
Germinoma germ cell tumors that start in the brain are most often treated with large doses of radiotherapy (high energy x-rays) with excellent cure rates. However, there is concern about the late effects of such treatment. Late effects are problems that arise later in life after treatment is completed such as learning difficulties, lower amounts of hormones or other problems in performing daily activities, depending on what area of the brain is treated with radiation therapy.
One of the goals of this study is to find out if using chemotherapy (anti-cancer drugs) and lower amounts of radiation therapy give the same results (cure rate) while lowering the late effects of higher doses of radiation therapy.

This is a phase III study, where patients are randomly assigned to either standard therapy such as radiotherapy (Regimen A) or experimental therapy (Regimen B) where patients receive both chemotherapy and radiotherapy in order to determine which treatment is better and/or safer. When patients enroll on this study they will be randomized to one of the two treatment arms. Randomization means that the treatment will be decided by chance, as in flipping a coin. This is done with a computer program. The two treatment arms are:

- Regimen A (this is the standard treatment with high doses of radiation therapy)
- Regimen B (this is treatment with chemotherapy and lower doses of radiation
therapy)

Both types of treatments have been shown in other smaller studies to be effective in bringing about long term remission, or control of the CNS germinoma.

Why Is This Study Being Done?
This study is being done to find out:
? The study is being done to try to reduce the frequency and severity of late effects without reducing the likelihood of cure.
? If the level of a protein called human chorionic gonadotrophin (HCG) that the tumor can release into the blood or CSF (the cerebrospinal fluid that surrounds the brain and spinal cord) can be used to tell how well each regimen will work.
? If there is any difference in the chance of being cured or having the cancer come back if the tumor has already spread by the time of diagnosis.
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