Clinical trial · Interventional
Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sargramostim | Biological | — | UNRESOLVED |
| telomerase: 540-548 peptide vaccine | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
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 vaccineReferences
Publications (0)
Data not yet available