Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
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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 |
Biological: sargramostim Biological: telomerase: 540-548 peptide vaccine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF |
| Study Start Date: | December 2000 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
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.
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:
- 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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | William Haining, MD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00069940 History of Changes |
| Other Study ID Numbers: | 03-365, P30CA006516 |
| Study First Received: | October 3, 2003 |
| Last Updated: | December 26, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Dana-Farber Cancer Institute:
|
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 |
Additional relevant MeSH terms:
|
Brain Neoplasms Nervous System Neoplasms Central Nervous System Neoplasms Gastrointestinal Stromal Tumors Sarcoma Neoplasms by Site Neoplasms Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 19, 2013