Brain and Central Nervous System TumorsPhase 1NCT00069940
Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
A Phase 1 study testing sargramostim and telomerase: 540-548 peptide vaccine in people with Brain and Central Nervous System Tumors and Gastrointestinal Stromal Tumor, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Gastrointestinal Stromal Tumor, Sarcoma
- What is being tested?
- sargramostim and telomerase: 540-548 peptide vaccine
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- Being tested
- sargramostim, telomerase: 540-548 peptide vaccine
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Gastrointestinal Stromal Tumors, Sarcoma, Glioblastoma, Sarcoma, Synovial, Leiomyosarcoma, Liposarcoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sargramostimBiological
telomerase: 540-548 peptide vaccineBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study startDec 2000
- Primary completionAug 2006
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- W. Nicholas Haining, BM, BCh, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069940
- Sponsor's protocol ID
- 03-365
- Other IDs
- P30CA006516
- Status last verified
- Dec 2010
- First submitted
- 3 Oct 2003
- Last updated
- 28 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF
- ClinicalTrials.gov ID
- NCT00069940
- Acronym / sponsor ID
- 03-365
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2000
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 7 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sargramostim | Biological | – |
| telomerase: 540-548 peptide vaccine | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. Nicholas Haining, BM, BCh study chair
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sargramostim and telomerase: 540-548 peptide vaccine in people with Brain and Central Nervous System Tumors and Gastrointestinal Stromal Tumor, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2010; AzTrials last refreshed its copy on 7 Nov 2026.