Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF

Conditions
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Sarcoma, Brain and Central Nervous System Tumors, Gastrointestinal Stromal Tumor

Intervention / Treatment
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* Biological: sargramostim
* Biological: telomerase: 540-548 peptide vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: sargramostim|nan|
|Biological: telomerase: 540-548 peptide vaccine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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