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

NCT ID: NCT00069940

Last Updated: 2010-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-31
• Study Completion Date: 2008-08-31

Brief 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.

Conditions

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

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

sargramostim

Intervention Type: BIOLOGICAL

telomerase: 540-548 peptide vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Dana-Farber Cancer Institute

Principal Investigators

W. Nicholas Haining, BM, BCh

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Locations

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

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

P30CA006516

Identifier Type: NIH

Identifier Source: secondary_id

View Link

03-365

Identifier Type: -

Identifier Source: org_study_id