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| Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00069940 |
Purpose
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 |
|
Brain and Central Nervous System Tumors Gastrointestinal Stromal Tumor Sarcoma |
Drug: sargramostim Drug: telomerase: 540-548 peptide vaccine |
Phase I |
| MedlinePlus related topics: | Brain Cancer Cancer Childhood Brain Tumors Soft Tissue Sarcoma |
| Drug Information available for: | Sargramostim Granulocyte-macrophage colony-stimulating factor |
| 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.
Eligibility
| 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
Contacts and Locations| United States, Massachusetts | |||||
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| Dana-Farber Cancer Institute |
| National Cancer Institute (NCI) |
| Study Chair: | W. Nicholas Haining, BM, BCh | Dana-Farber Cancer Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000301622, DFCI-02100 |
| First Received: | October 3, 2003 |
| Last Updated: | November 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00069940 |
| Health Authority: | United States: Federal Government |
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