Sarcoma

Clinical Trials

Below is a list of Sarcoma 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 2 Study of Sulindac (Clinoril) and Tamoxifen in Patients with Desmoid Tumors that are Recurrent or Not Amenable (Not Responding) to Standard Therapy
This study is being done to:
- Find the effects (good and bad) when combining sulindac and tamoxifen
- Find out if sulindac and tamoxifen are helpful in treating desmoid tumors
- Study tumor samples in a laboratory and find out if there is a way to tell if tumor cells will respond to treatment with sulindac and tamoxifen

Patients are being asked to take part in this study because they have a rare soft tissue tumor called a desmoid tumor (desmoid tumors are also called fibromatosis or aggressive fibromatosis). Surgery and/or radiation therapy are the standard treatment for these tumors, but sometimes, because of the location or size of the tumor, it is not possible to do surgery and/or radiation therapy. In other cases, these treatments are done and the tumor comes back (this is called recurrent tumor). Patients are being asked to take part in this study because their tumor cannot be treated with surgery and/or radiation, or because the tumor has come back.

Sulindac is a drug approved to treat inflammation in patients with arthritis. Several published reports suggest that sulindac may have anti-tumor activity in adults with desmoid tumor. Tamoxifen is an estrogen-blocking drug approved for the treatment of breast cancer. Researchers have reported that tamoxifen may have anti-tumor activity against desmoid tumors. Sulindac and tamoxifen have been investigated, separately and together, in recent clinical studies of adults and children with different types of tumor, including desmoid tumor. Pediatric researchers would like to find out if this combination of sulindac and tamoxifen, taken by mouth, can be taken by children and if this combination has anti-tumor activity against desmoid tumor in children whose tumor cannot be treated with surgery or radiation therapy or whose desmoid tumor has come back.
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Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma
This study is being done to:
- Improve the outcome of patients with Ewing's sarcoma.
- Compare the survival of patients in a study of:
- standard drug treatment and whole lung irradiation versus
- high dose, stronger drug treatment followed by replacement of peripheral blood stem cells (transplant). Stem cells are the cells that create new blood cells, such as red blood cells, white blood cells, and platelets. They can be found in the peripheral blood (bloodstream) or the soft tissue of the bone, called the bone marrow.

Patients are being asked to take part in this study because they have a type of cancer called Ewing's sarcoma that has spread to the lung or pleura (lining of the lung and chest cavity).
Ewing's sarcoma is a cancerous tumor that forms in the bone or soft connective tissues.
These tumors spread quickly to other areas of the body including the lungs. Ewing's
sarcoma is always fatal without treatment.

The standard treatment for patients with Ewing's sarcoma with disease that has spread to the lungs or pleura is standard dose chemotherapy and whole lung radiation therapy. It is possible that stronger chemotherapy, using high doses of standard chemotherapy drugs may improve the outcome (survival) for these patients. However, the side effects of using both whole lung radiation therapy and high dose chemotherapy would be too much to combine these treatments.
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Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors
This is a study for children and young adults with high-risk cancers that usually start in the kidney. The study was designed for patients with anaplastic Wilms' tumor, malignant rhabdoid tumor, clear cell sarcoma of the kidney, and renal cell carcinoma. These tumors are called "high-risk" tumors because they are likely to spread to other areas of the body and/or come back during or after treatment. The high-risk kidney tumors are very rare; only about 50 children and young adults are diagnosed with a high-risk kidney tumor each year in North America. This study has different treatment "arms" that vary according to the stage and type of the tumor.
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Monoclonal Antibody, Bevacizumab (Avastin), for Treating Angiosarcoma (NU04S1)
This research study involves the use of a drug called Bevacizumab. Bevacizumab is currently approved by the Food and Drug Administration (FDA) as a treatment for patients with metastatic colon cancer. It is not approved as a treatment for angiosarcoma, so it is considered experimental in this study. Bevacizumab works by blocking a substance in a persons body called endothelial growth factor, or VEGF. VEGF is found in many normal tissues and is important in the making of new blood vessels (both normal and abnormal) in a persons body. Cancerous tumors may cause too much VEGF to be made. This study is being done to find out what effects (good and bad) Bevacizumab has on a patient and angiosarcoma; find out what side effects this drug causes and how often they happen.
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Multi-Drug Therapy, Including Ifosfamide/Etoposide (IE) and Vincristine/Doxorubicin/Cyclophosphamide (VDC) for Patients with High-Risk Rhabdomyosarcoma
Patients are being asked to take part in this research study because they have been diagnosed with rhabdomyosarcoma or a similar tumor called an ectomesenchymoma.
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues (like muscles). For patients eligible for this study, the patient's tumor is considered high risk because there is a high risk that their tumor will return after treatment. This is because the tumor has already grown beyond the site where it started and invaded other tissues in the patient's body.
It is common to enroll children and adolescents with cancer in a clinical trial that seeks to improve cancer treatment over time. Clinical trials include only people who choose to take part. Patients have a choice between a standard treatment for rhabdomyosarcoma and this clinical trial.

What is the Current Standard of Treatment for this Disease?
The standard treatment for high risk rhabdomyosarcoma patients is surgery to remove the tumor (if possible), and using anti-cancer drugs (chemotherapy) and high energy X-rays (radiation therapy). The standard drugs used to treat rhabdomyosarcoma are vincristine, dactinomycin and cyclophosphamide. This is often called VAC therapy.

VAC therapy does not work as well with tumors that have already spread at the time a patient is diagnosed. Past studies have been done using higher doses of cyclophosphamide but that has not increased the survival rates for high risk patients.

Study doctors now want to try a new experimental approach that will add other drugs to VAC while giving the drugs more often (called interval compression) which means the patient
gets more drugs earlier in their treatment plan. The drugs chosen, ifosfamide, etoposide, doxorubicin and irinotecan, have been used in other studies for patients with rhabdomyosarcomas and other kinds of sarcomas.

The overall goals of this study are to:
- Find out the effects, good and bad, of giving high intensity chemotherapy to patients with high risk rhabdomyosarcoma or ectomesenchymoma
- Find out the effects, good and bad, of giving irinotecan at the same time as radiation therapy.
- See if early exposure to high intensity chemotherapy will get rid of the cancer for as long as possible for high risk rhabdomyosarcoma patients
- Find out if the addition of more drugs to the VAC regimen will get rid of the cancer for as long as possible for high risk rhabdomyosarcoma subjects
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Optimizing Treatment Strategies for Surgically Treatable Osteosarcoma, Based on Response to Pre-operative Chemotherapy.
Study doctors would like to find out how best to treat subjects with osteosarcoma by comparing how subjects do when treated with different anti-cancer drugs. The standard anti-cancer drugs used to treat subjects with osteosarcoma are methotrexate, doxorubicin (also called adriamycin) and cisplatin. These three drugs together are called MAP. This study is being done to:
- See if adding ifosfamide and etoposide (VP-16) to chemotherapy will help get rid of the disease in subjects who have a poor tumor response to MAP alone.
- See if adding a "biologic" drug called interferon after MAP chemotherapy can help get rid of the disease in subjects who have a good tumor response to standard chemotherapy. This study will use pegylated interferon alfa-2b, interferon that has been changed to last longer in the body so it can be given less often.
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Phase 3 Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS)
The current standard treatment for rhabdomyosarcoma (RMS) is surgery to remove as much tumor as possible, chemotherapy (anti-drug therapy) with vincristine, dactinomycin and cyclophosphamide (together called VAC therapy), and, for almost all tumors, radiation therapy (treatment with high energy X-rays).
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Risk-Based Treatment for Pediatric Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS)
Patients are being asked to take part in this study because they have a type of cancer called a non-rhabdomyosarcoma soft tissue sarcoma (NRSTS). Non-rhabdomyosarcoma soft tissue sarcomas are rare tumors and little is known about them. At the present time, doctors do not always know what the best treatment will be for a patient with one of these tumors. Studies done in both children and adults with NRSTS have shown that the amount of treatment a patient needs may be based on the risk group of the tumor.

Tumors are assigned a risk group based on features that influence how they behave. For NRSTS, the risk group is based on the type of cells in the tumor (the grade of the tumor), the size of the tumor, if the tumor has spread to other areas of the body, and how much of the tumor can be taken out by surgery. Patients with tumors in the low risk group may be cured with mild treatment, in some cases only surgery. Patients with tumors in the intermediate and high risk groups may need more treatment, including anti-cancer drugs (chemotherapy) and high energy X-ray therapy (radiation therapy).

It is common to enroll children and adolescents with cancer in a clinical trial that seeks to improve cancer treatment over time. Clinical trials include only people who choose to take part. Patients have a choice between a standard treatment for NRSTS and this clinical trial. Patients with NRSTS are commonly treated with surgery, radiation therapy and/or chemotherapy. The type(s) of treatment used depend on the type of tumor and the risk group.
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The Use of Chemotherapy Medications, Gemcitabine (Gemzar) and Docetaxel (Taxotere) in the Treatment of Ewing's Sarcoma, Osteosarcoma, or Chondrosarcoma
This study is being done to:
-See if the chemotherapy drugs gemcitabine (Gemzar) and docetaxel (Taxotere), when given together, may help to fight cancer of the bone or soft tissue. Each of these drugs is approved by the US Food and Drug Administration (FDA) for the treatment of some kinds of cancer, such as cancer of the pancreas and lung, but they are not approved for this type of cancer, so in this study they are called investigational drugs.
-See what effects (good and bad) gemcitabine and docetaxel have on the patient and the tumor.
-See how a patient's body processes the gemcitabine and docetaxel.
-(When possible), to do genetic research studies on a sample of a patient's tumor tissue.
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Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients with Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma
This study is being done to:
- Find out the most effective treatment with the least amount of therapy that will still cure patients with low risk rhabdomyosarcoma

Results of past research studies with low-risk rhabdomyosarcoma patients show that using the three chemotherapy medicines (including cyclophosphamide) helps to cure more patients, but cyclophosphamide at the high doses that were used in these past studies can cause late effects.

The goals of this study are to see if:
1. Lower doses of cyclophosphamide used together with current standard doses of vincristine and dactinomycin can be as effective or better in curing patients as using the standard doses of vincristine and dactinomycin
2. The length of treatment can be shortened
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