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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00069940 |
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 | Intervention | Phase |
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Brain and Central Nervous System Tumors Gastrointestinal Stromal Tumor Sarcoma |
Drug: sargramostim Drug: telomerase: 540-548 peptide vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF |
Study Start Date: | December 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of 1 of the following malignancies:
Stage III or IV sarcoma, including:
Brain tumor, including:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Study Chair: | W. Nicholas Haining, BM, BCh | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000301622, DFCI-02100 |
Study First Received: | October 3, 2003 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00069940 |
Health Authority: | United States: Federal Government |
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 |
Glioblastoma Digestive System Neoplasms Astrocytoma Gastrointestinal Diseases Leiomyosarcoma Synovial sarcoma Malignant mesenchymal tumor Central Nervous System Neoplasms Soft tissue sarcomas Recurrence Ependymoma Sarcoma, Synovial |
Neoplasms, Connective and Soft Tissue Brain Neoplasms Liposarcoma Digestive System Diseases Sarcoma Gastrointestinal Neoplasms Oligodendroglioma Glioma Gastrointestinal Stromal Tumors Gliosarcoma Nervous System Neoplasms |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Nervous System Diseases |