I'm going to add current Clinical Trials that include the words soft tissure sarcoma, Ewing's Family of Tumors, and desmoplastic small round cell tumor.
I'm just listing them here, not advocating them in any way. Please read through them carefully and make your best determination if they apply to your individual case or not.
clinicalstudies.info.nih.gov/detail/A_2002-C-0259.htmlProtocol Number: 02-C-0259
Title: Pilot Study of Allogeneic/Syngeneic Blood Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas Number: 02-C-0259
Summary: This study will examine the safety and effectiveness of stem cell transplantation for treating patients with sarcomas (tumors of the bone, nerves, or soft tissue). 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 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 been diagnosed by the age of 30 and may be no older than age 35 at the time of enrollment. They must have a matched donor (usually a sibling). Participants undergo the following procedures:
Donors: Stem cells are collected from the donor. To do this, the hormone G-CSF is injected under the skin for several days to move stem cells out of the bone marrow into the bloodstream. Then, the cells are collected by apheresis. In this procedure the blood is drawn through a needle placed in one arm and pumped into a machine where the stem cells are separated out and removed. The rest of the blood is returned to the donor through a needle in the other arm.
Patients: For patients who do not already have a central venous catheter (plastic tube), one is placed into a major vein. This tube can stay in the body during the entire treatment period and is used to give medications, transfuse blood, if needed, withdraw blood samples and delivering the donated stem cells. Before the transplant procedure, patients receive from one to three cycles of "induction" chemotherapy, with each cycle consisting of 5 days of fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone followed by at least a 17-day rest period. All the drugs are infused through the catheter except prednisone, which is taken by mouth. After the induction therapy, the patient is admitted to the hospital for 5 days of chemotherapy with high doses of cyclophosphamide, melphalan and fludarabine. Two days later, the stem cells are infused. The anticipated hospital stay is about 3 weeks, but may be longer if complications arise. Patients are discharged when their white cell count is near normal, they have no fever or infection, they can take sufficient food and fluids by mouth, and they have no signs of serious graft-versus-host disease (GVHD)-a condition in which the donor's cells "see" the patient's cells as foreign and mount an immune response against them.
After hospital discharge, patients are followed in the clinic at least once or twice weekly for a medical history, physical exam, and blood tests for 100 days. They receive medications to prevent infection and GVHD and, if needed, blood transfusions. If GVHD has not developed after 28 days, patients receive additional white cells to boost the immune response. After 100 days, follow-up visits may be less frequent. Follow-up continues for at least 5 years. During the course of the study, patients undergo repeated medical evaluations, including blood tests and bone marrow aspirations, to check on the cancer and on any treatment side effects. On four occasions, white blood cells may be collected through apheresis to see if immune responses can be generated against the sarcomas treated in this study. Positron emission tomography (PET) scans may be done on five occasions. This test uses a radioactive material to produce images useful in detecting primary tumors and cancer that has spread.
Sponsoring Institute:
National Cancer Institute (NCI)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None
Eligibility Criteria:
INCLUSION CRITERIA - PATIENT:
The following diagnoses will be considered:
a) Patients with Ewing's sarcoma family of tumors, or alveolar rhabdomyosarcoma in one of the following categories:
Patients who present at the time of initial diagnosis with macrometastatic disease (except patients with Ewing's sarcoma metastatic to lung only) may be enrolled after completion of standard front-line therapy. Standard front line therapy for alveolar rhabdomyosarcoma should include vincristine and cyclophosphamide, plus actinomycin D and/or adriamycin. For patients with Ewing's sarcoma, standard front line therapy should include vincristine, cyclophosphamide, adriamycin, ifosfamide and etoposide.
Patients with recurrence of tumor at any site les than one year after completing standard front-line therapy or with a second or subsequent recurrence at any time after completing standard front-line therapy.
Patients with progression of disease while receiving standard front-line chemotherapy who cannot achieve a CR with local treatment modalities.
b) The following patients with desmoplastic small round cell tumor are eligible after receiving front line standard therapy which is defined as a regimen containing at least vincristine, cyclophosphamide, and adriamycin:
-unresectable disease
-metastatic tumor (abdominal and extra-abdominal disease)
-progressive while receiving standard therapy
-recurrence within one year of completing therapy
Patients without evaluable tumor at the time of enrollment are eligible.
Patients who have previously received high-dose chemotherapy with autologous stem cell rescue are eligible for this trial.
Patient age of greater than 4 years at enrollment, less than 30 years at diagnosis and age less than 35 at enrollment.
Availability of a 5 or 6 antigen HLA-matched first-degree relative donor (single HLA-A or B mismatch allowed). Genotypically identical twins may serve as stem cell donors. Genotypic identity must be confirmed by RFLP analysis.
ECOG performance status of 0, 1, or 2 or, for children less than 10 years of age, Lanskygreater than or equal to 60(Appendix A).
Life expectancy greater than 3 months.
Cardiac function: Left ventricular ejection fraction greater than or equal to 45% by MUGA, fractional shortening greater than or equal to 28% by ECHO or left ventricular ejection fraction greater than or equal to 55% by ECHO.
Pulmonary function: DLCO greater than or equal to 50% of the expected value corrected for alveolar volume.
Renal function: Age-adjusted normal serum creatinine according to the following or a creatinine clearance greater than or equal to 60 ml/min/1.73 m(2).
Age less than or equal to 5 years with a maximum serum creatinine (mg/dl) of 0.8.
Age greater than 5 years, less than or equal to 10 years with a maximum serum creatinine (mg/dl) of 1.0.
Age greater than 10 years, less than or equal to 15 with a maximum serum creatinine (mg/dl) of 1.2.
Age greater than 15 years with a maximum serum creatinine (mg/dl) of 1.5.
Liver function: Serum total bilirubin less than 2 mg/dl, serum AST and ALT less than or equal to 2.5 x upper limit of normal.
Marrow function: ANC must be greater than 750/mm(3) (unless due to underlying disease in which case there is no grade restriction), platelet count must be greater than or equal to 75,000/mm(3) (not achieved by transfusion) unless due to underlying disease in which case there is no grade restriction). Lymphopenia, CD4 lymphopenia, leukopenia, and anemia will not render patients ineligible.
Ability to give informed consent. For patients less than 18 years of age their legal guardian must give informed consent. Pediatric patients will be included in age-appropriate discussion in order to obtain verbal assent.
Durable power of attorney form completed (patients greater than or equal to 18 years of age only).