Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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 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 Contact Information

Trial Lead Organizations/Sponsors

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

W. Nicholas Haining

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00069940
Information obtained from ClinicalTrials.gov on December 14, 2011

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