Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
This study is ongoing, but not recruiting participants.
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
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 2000
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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069940

Locations
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: W. Nicholas Haining, BM, BCh Dana-Farber Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000301622, DFCI-02100
Study First Received: October 3, 2003
Last Updated: November 22, 2008
ClinicalTrials.gov Identifier: NCT00069940  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Glioblastoma
Digestive System Neoplasms
Astrocytoma
Gastrointestinal Diseases
Leiomyosarcoma
Synovial sarcoma
Malignant mesenchymal tumor
Central Nervous System Neoplasms
Soft tissue sarcomas
Recurrence
Ependymoma
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Brain Neoplasms
Liposarcoma
Digestive System Diseases
Sarcoma
Gastrointestinal Neoplasms
Oligodendroglioma
Glioma
Gastrointestinal Stromal Tumors
Gliosarcoma
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009