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.

Condition	Treatment or Intervention	Phase
Brain Tumor childhood brain tumor childhood soft tissue sarcoma gastrointestinal stromal tumor Muscle Cancer	Drug: sargramostim  Drug: telomerase: 540-548 peptide vaccine  Procedure: biological response modifier therapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: non-tumor cell derivative vaccine  Procedure: vaccine therapy	Phase I

Further Study 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.

Ages Eligible for Study:  2 Years and above,  Genders Eligible for Study:  Both

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

Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States

Study chairs or principal investigators

W. Nicholas Haining, BM, BCh,  Study Chair,  Dana-Farber/Harvard Cancer Center   

Study ID Numbers:  CDR0000301622; DFCI-02100; NCT00069940
Record last reviewed:  February 2005
Last Updated:  February 17, 2005
Record first received:  October 3, 2003
ClinicalTrials.gov Identifier:  NCT00069940
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08