Brain and Central Nervous System Tumors, Gastrointestinal Stromal Tumor, Sarcoma
Conditions
Keywords
adult glioblastoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, adult synovial sarcoma, childhood synovial sarcoma, childhood leiomyosarcoma, adult leiomyosarcoma, adult liposarcoma, childhood liposarcoma, gastrointestinal stromal tumor, recurrent childhood brain tumor, recurrent adult brain tumor, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, recurrent adult soft tissue sarcoma, adult giant cell glioblastoma, adult gliosarcoma, adult anaplastic astrocytoma, adult oligodendroglioma, adult anaplastic oligodendroglioma, adult diffuse astrocytoma, adult mixed glioma, adult myxopapillary ependymoma, adult anaplastic ependymoma, childhood high-grade cerebral astrocytoma, recurrent childhood cerebral astrocytoma, untreated childhood cerebellar astrocytoma, recurrent childhood cerebellar astrocytoma, childhood infratentorial ependymoma, newly diagnosed childhood ependymoma, recurrent childhood ependymoma, childhood oligodendroglioma
Brief summary
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: This phase I trial is studying the side effects of vaccine therapy when given together with sargramostim in treating patients with advanced sarcoma or brain tumor.
Detailed description
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.
Interventions
BIOLOGICALsargramostim
BIOLOGICALtelomerase: 540-548 peptide vaccine
Sponsors
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed