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Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas Clinical research trials and Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas. Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas clinical trial. Test subjects typically obtain the finest healthcare available for their Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas  Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas
Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas
For Condition: Sarcoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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 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). Participants will 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 the entire treatment period for giving medications, transfusing blood, if needed, withdrawing 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 4 days of chemotherapy with high doses of cyclophosphamide, melphalan, and fludarabine. Three 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. They receive medications to prevent infection and GVHD and, if needed, blood transfusions. After the first 100 days, the risk of serious complications decreases and 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 are collected through apheresis to see if immune responses can be generated against the sarcomas treated in this study. Positron emission tomography (PET) scans are done on five occasions. This test uses a radioactive material to produce images useful in detecting primary tumors and cancer that has spread.
Details: Although the treatment of pediatric sarcomas has enjoyed progress in the past 25 years for patients with localized, chemosensitive disease, prognostic factors are now available to identify subsets of patients who have very dismal prognoses. This includes patients with primary metastatic disease, especially those with bone and bone marrow metastases. In addition, patients with primary chemoresistant disease and early recurrence also have very poor prognoses and lack suitable treatment options. For these patients, it is critical that alternative approaches to cytotoxic chemotherapy be identified. Basic laboratory studies have shown that Ewing's sarcoma is susceptible to immune mediated mechanisms of cytolysis in vitro. Interestingly, for Ewing's sarcoma this appears to be true for both chemosensitive and chemoresistant cell lines. Furthermore, recent progress in the field of bone marrow transplantation has identified approaches that can reproducibly induce allogeneic peripheral blood stem cell engraftment in adults with hematologic malignancies. In some cases, this same approach has shown beneficial effects for patients with solid tumors as a result of the development of allogeneic, immune-mediated graft versus tumor effects. Based upon this background, we propose to undertake an allogeneic PBSCT transplant in patients with matched first degree related donors for high-risk pediatric sarcomas. Endpoints will be feasibility and toxicity of this approach as well as evaluation for any evidence of graft vs. tumor effects. This protocol will also provide a platform for the future development of tumor-specific vaccines that could be administered following allogeneic PBSCT in an attempt to specifically direct graft-versus-tumor responses toward pediatric sarcomas.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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 with recurrence of tumor at any site less 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. Standard front line therapy for alveolar rhabdomyosarcoma should include vincristine/cyclophosphamide and 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 unless progression or recurrence is identified while receiving standard front-line therapy or on first post-therapy evaluation done within four weeks of completing standard front-line therapy. Patients who have previously received high-dose chemotherapy with autologous stem cell rescue are eligible for this trial at a minimum of 8 weeks after completion of autologous BMT. 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 or equal to 10 years of age, Lansky greater than or equal to 60. Life expectancy greater than 3 months. Cardiac function: Left ventricular ejection fraction greater than 45% by MUGA or fractional shortening greater than or equal to 28%. Pulmonary function: DLCO greater than 50% of the expected value. Renal function: Age-adjusted normal serum creatinine according to the following or a creatinine clearance greater than 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). INCLUSION CRITERIA - DONOR: Weight greater than or equal to 15 kilograms. First degree relative with genotypic identity at 5 or 6 HLA loci (single HLA-A or B locus mismatch allowed). Genotypically identical twins may serve as stem cell donors. Genotypic identity must be confirmed by RFLP analysis. For donors less than 18 years of age, he/she must be the oldest suitable donor, their legal guardian must give informed consent, donors greater than 7 and less than 18 must give verbal assent, and he/she must be cleared by social work and a mental health specialist to participate. For donors greater than or equal to 18 years of age, ability to give informed consent. Adequate peripheral venous access for apheresis or consent to use a temporary central venous catheter for apheresis. Donor selection criteria will be in accordance with NIH/CC Department of Transfusion Medicine standards. EXCLUSION CRITERIA - PATIENT: Uncontrolled fungal infection. History of CNS tumor involvement. Extradural masses which have not invaded the brain parenchyma (as is commonly observed in Ewing's sarcoma family of tumors) or parameningeal tumors (as is commonly observed in rhabdomyosarcoma) without evidence for leptomeningeal spread will not render the patient ineligible. Lactating or pregnant females. HIV positive (due to unacceptable risk following allogeneic transplantation). Hepatitis B surface antigen (HBsAg) positive or hepatitis C antibody positive with elevated liver transaminases. All patients with chronic active hepatitis (including those on treatment) are ineligible. High risk of inability to comply with transplant protocol, or inability to give appropriate informed consent in the estimation of the PI, social work, or the stem cell transplant team. Fanconi Anemia. EXCLUSION CRITERIA - DONOR: History of medical illness which poses a risk to donation in the estimation of the PI or the Department of Transfusion Medicine physician including, but not limited to stroke, hypertension that is not controlled with medication, or heart disease. Individuals with symptomatic angina or a history of coronary bypass grafting or angioplasty will not be eligible. History of congenital hematologic, immunologic, oncologic or metabolic disorder, which poses a prohibitive risk to the recipient in the estimation of the PI. Anemia (Hb less than 11 gm/dl) or thrombocytopenia (less than 100,000/microliters). Lactating or pregnant females. Donors of childbearing potential must use an effective method of contraception during the time they are receiving G-CSF. The effects of cytokine administration on a fetus are unknown and may be potentially harmful to the infant. HIV-positive, hepatitis B surface antigen (HBsAg) positive or hepatitis C antibody positive. Donors are providing an allogeneic blood product and there is the potential risk of transmitting these viral illnesses to the recipient. High risk of inability to comply with transplant protocol.
Total Enrollment: 62
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020259; 02-C-0259
Study Start Date: August 8, 2002
Record last reviewed: January 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043979
Other Sarcoma Studies:
1. The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities
2. A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas
3. Temozolomide and O6-Benzylguanine for Treating Childhood Cancers
4. Phase II Trial of Gleevec (STI571) in Patients with Advanced Soft Tissue or Bone Cancer
5. Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity
Related Studies:
Other Sarcoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas
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