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Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor Clinical research trials and Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor medical trials happen in hundreds of localities 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 typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor. Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor clinical trial. Participants frequently obtain the most expert healthcare available for their Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor  Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
For Condition: Brain Tumor,gastrointestinal stromal tumor,Muscle Cancer,childhood brain tumor,childhood soft tissue sarcoma
Status: Recruiting
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with sargramostim in treating patients who have advanced sarcoma or brain tumor.
Details: OBJECTIVES: - Determine the feasibility of treatment with telomerase: 540-548 peptide vaccine and sargramostim (GM-CSF) in patients with sarcoma or brain tumor. - Determine the safety and tolerability of this regimen in these patients. - Determine the frequency of T-cell specific vaccine antigens during and after administration of this regimen in these patients. - Determine, preliminarily, the clinical response, if any, of patients treated with this regimen. OUTLINE: Patients receive telomerase: 540-548 peptide vaccine subcutaneously (SC) on day 3 and sargramostim (GM-CSF) SC on days 1-4 of weeks 1, 3, 5, 7, 9, 11, 15, 19, and 23. PROJECTED ACCRUAL: A total of 35 patients (20 adult and 15 pediatric) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 2 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed diagnosis of 1 of the following malignancies: - Stage III or IV sarcoma, including: - Leiomyosarcoma - Synovial cell sarcoma - Liposarcoma - Gastrointestinal stromal tumor - Brain tumor, including: - Diffuse pontine glioma* - Glioblastoma multiforme - Glialsarcoma NOTE: *For patients with diffuse pontine glioma, the requirement for histologic verification may be waived - No known curative therapy - HLA A*0201 positive by genotyping PATIENT CHARACTERISTICS: Age - Over 2 Performance status - Karnofsky 60-100% (patients over age 16) - Lansky 60-100% (patients under age 16) Life expectancy - Not specified Hematopoietic - WBC greater than 3,000/mm^3 - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic - AST and ALT less than 2.5 times upper limit of normal (ULN) - Bilirubin less than 1.5 times ULN Renal - Creatinine less than 1.5 times ULN Cardiovascular - No clinically significant cardiovascular disease Pulmonary - No clinically significant pulmonary disease PRIOR CONCURRENT THERAPY: Biologic therapy - No prior hematopoietic stem cell transplantation - No other concurrent vaccine therapy - No other concurrent immunotherapy Chemotherapy - No prior chemotherapy - No concurrent chemotherapy Endocrine therapy - Concurrent dexamethasone allowed provided patient has been on a decreasing dose for the past 2 weeks and the current dose is the lowest clinically acceptable dose (ideally, less than 9-12 mg/day) Radiotherapy - No prior extensive-field radiotherapy that would compromise bone marrow function - At least 2 weeks since prior local radiotherapy Surgery - At least 2 weeks since prior surgery Other - At least 2 weeks since prior imatinib mesylate - No concurrent local anesthetic to administration site of vaccine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
W.Haining, Study Chair, Dana-Farber/Harvard Cancer Center
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting W. Haining 617-632-5293
Additional Information:
Study ID Numbers: CDR0000301622; DFCI-02100
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069940
Other Childhood Brain Tumor Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Cancer
2. Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma
3. Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors
4. Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas
5. Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma
Related Studies:
Other childhood brain tumor Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
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