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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
sargramostim
telomerase: 540-548 peptide vaccine
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 3, 2003
Last Updated
December 26, 2010
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00069940
Brief Title
Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
Official Title
A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Biological
Intervention Name(s)
telomerase: 540-548 peptide vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W. Nicholas Haining, BM, BCh
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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

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