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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00069940

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors Gastrointestinal Stromal Tumor Sarcoma	Biological: sargramostim Biological: telomerase: 540-548 peptide vaccine	Phase 1

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.

Study Design

Study Type:

Interventional

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF

Study Start Date :

Dec 1, 2000

Actual Primary Completion Date :

Aug 1, 2006

Actual Study Completion Date :

Aug 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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