Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

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

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.

Eligibility: 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

Relevance to patient case: not relevant