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

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 1

Conditions: Sarcoma; Brain and Central Nervous System Tumors; Gastrointestinal Stromal Tumor

Treatments: Biological: sargramostim; Biological: telomerase: 540-548 peptide vaccine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00069940

P30CA006516 (U.S. NIH Grant/Contract)

03-365

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)