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Clinical Trials involving Stem Cell Transplantation The Q&A Column in this issue of ESUN deals with Stem Cell Transplantation. The following five clinical trials all involve stem transplantation and are currently open to sarcoma patients. An additional stem cell transplantation clinical trial is presented in the April 2004 Issue Clinical Trials News Column of ESUN.
Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas This Phase I clinical trial is currently recruiting patients. This study will investigate the safety and effectiveness of using stem cell transplantation for treating patients with sarcomas (tumors of the bone, nerves, or soft tissue). The investigators explain, “Stem cells are immature cells in the bone marrow and blood stream that develop into blood cells. In patients with certain cancers, such as leukemia and lymphoma, stem cells transplanted from a healthy donor travel to the patient's bone marrow and begin producing normal cells. In addition, the donor's immune cells attack the patient's cancer cells in what is called a graft-versus-tumor effect, contributing to cure of the disease.” This study will determine whether this treatment can be used successfully to treat patients with sarcomas. Patients between 5 and 29 years of age with a sarcoma that has spread from the primary site or cannot be removed surgically, and for whom effective treatment is not available, may be eligible for this study. Candidates must have a matched donor (usually a sibling).
Stem Cell Transplantation for Metastatic Solid Tumors This Phase II clinical trial is currently recruiting patients. The goal of this trial is to identify other types of cancer (malignant neoplasms) that may be treatable with stem cell transplantation (allogenic peripheral blood stem cell transplantation). Patients with a variety of different types of cancerous tumors that have spread (metastasized) and whose conditions have not improved with standard therapy, will be eligible to participate. Those patients selected to participate in the study will undergo a procedure known as a "mini-transplant". The investigators state, “The mini-transplant is a transplantation of stem-cells collected from a sibling (brother or sister) of the patient. Unlike traditional bone marrow transplants, the mini-transplant does not require intense chemotherapy or radiation therapy. Because of this, patients experience fewer and less severe side effects.” The study is open to patients diagnosed with a variety of metastatic solid tumors including bony/soft tissue sarcoma.
This Phase III clinical trial is currently recruiting patients. The investigators set forth the rationale for this study as follows, “Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.” The purpose of the trial is thus to compare the effectiveness of combination chemotherapy and peripheral stem cell transplantation with or without radiation therapy and/or surgery in treating patients who have a Ewing's sarcoma.
This Phase I clinical trial is currently recruiting patients. The investigators set forth the rationale for this study as follows, “Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.” The purpose of the trial is to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced cancer. A variety of cancers are eligible including soft tissue sarcoma, osteosarcoma, and Ewing’s sarcoma.
This Phase I/II clinical trial is currently recruiting patients. The investigators set forth the rationale for this study as follows, “Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.” The purpose of the trial is to study the effectiveness of the drug temozolomide plus peripheral stem cell transplantation in treating children who have newly diagnosed malignantglioma or recurrent central nervous system tumors or other solid tumors. Temozolomide is an alkylating agent whose primary use is against astrocytoma and glioblastoma. Other uses are against brain metastases from solid tumors. Persons up to 18 years of age with a variety of cancers including recurrent soft tissue sarcoma and recurrent Ewing’s sarcoma/primitive neuroectodermal tumors are eligible.
Clinical Trials involving ET-743 There is an article titled "ET-743: A Review of Recent Results" in this issue of ESUN. The following two clinical trials Et-743 and are currently open to sarcoma patients. An additional ET-743 clinical trial is presented in the April 2004 Issue Clinical Trials News Column of ESUN.
A Phase II Study of ET-743 in Subjects With Advanced Liposarcoma or Leiomyosarcoma This Phase II clinical trial study is currently recruiting patients. The purpose of this study is to test the safety and effectiveness of the investigational chemotherapy agent ET-743 in subjects with advanced liposarcoma or leiomyosarcoma. ET-743 is a cytotoxic alkaloid derived from a marine organism which covalently binds to the minor groove of DNA and may inhibit DNA replication and transcription through other mechanisms. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. Persons 18 years and older are eligible.
This Phase II clinical trial is not yet open for patient recruitment. The purpose of this study is to study the effectiveness of ecteinascidin 743 (ET-743) in treating young patients who have recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. ET-743 is a cytotoxic alkaloid derived from a marine organism which covalently binds to the minor groove of DNA and may inhibit DNA replication and transcription through other mechanisms. Conditions eligible for the study are histologically confirmed recurrent or refractory sarcomas, including the following: Rhabdomyosarcoma, Non-rhabdomyosarcomatous soft tissue sarcoma, and Ewing's sarcoma.
V1N3 ESUN Copyright © 2004 Liddy Shriver Sarcoma Initiative
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