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.
- 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
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
- Histologically or cytologically confirmed diagnosis of 1 of the following
- Stage III or IV sarcoma, including:
- Synovial cell sarcoma
- 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
- Over 2
- Karnofsky 60-100% (patients over age 16)
- Lansky 60-100% (patients under age 16)
- Not specified
- WBC greater than 3,000/mm^3
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
- AST and ALT less than 2.5 times upper limit of normal (ULN)
- Bilirubin less than 1.5 times ULN
- Creatinine less than 1.5 times ULN
- No clinically significant cardiovascular disease
- No clinically significant pulmonary disease
PRIOR CONCURRENT THERAPY:
- No prior hematopoietic stem cell transplantation
- No other concurrent vaccine therapy
- No other concurrent immunotherapy
- No prior chemotherapy
- No concurrent chemotherapy
- 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)
- No prior extensive-field radiotherapy that would compromise bone marrow function
- At least 2 weeks since prior local radiotherapy
- At least 2 weeks since prior surgery
- At least 2 weeks since prior imatinib mesylate
- No concurrent local anesthetic to administration site of vaccine