- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00069940
Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF
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.
Study Overview
Status
Intervention / Treatment
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 Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: W. Nicholas Haining, BM, BCh, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- childhood high-grade cerebral astrocytoma
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- recurrent adult brain tumor
- adult anaplastic astrocytoma
- adult anaplastic ependymoma
- adult anaplastic oligodendroglioma
- adult diffuse astrocytoma
- adult myxopapillary ependymoma
- adult oligodendroglioma
- adult mixed glioma
- adult leiomyosarcoma
- adult liposarcoma
- adult synovial sarcoma
- stage IV adult soft tissue sarcoma
- recurrent adult soft tissue sarcoma
- gastrointestinal stromal tumor
- untreated childhood cerebellar astrocytoma
- childhood infratentorial ependymoma
- newly diagnosed childhood ependymoma
- stage III adult soft tissue sarcoma
- childhood oligodendroglioma
- recurrent childhood cerebellar astrocytoma
- recurrent childhood cerebral astrocytoma
- recurrent childhood ependymoma
- recurrent childhood brain tumor
- metastatic childhood soft tissue sarcoma
- recurrent childhood soft tissue sarcoma
- childhood synovial sarcoma
- childhood leiomyosarcoma
- childhood liposarcoma
Additional Relevant MeSH Terms
- Digestive System Diseases
- Nervous System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Neoplasms, Connective Tissue
- Neoplasms
- Sarcoma
- Gastrointestinal Stromal Tumors
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Physiological Effects of Drugs
- Immunologic Factors
- Sargramostim
Other Study ID Numbers
- 03-365
- P30CA006516 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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