Clinical trial NCT00069940: Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
Official title: A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain and Central Nervous System Tumors
Gastrointestinal Stromal Tumor
Sarcoma
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
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
recurrent childhood ependymoma
childhood oligodendroglioma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-10-07
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: W. Nicholas Haining, BM, BCh
role: STUDY_CHAIR
References: