Full Text View
Tabular View
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.
Study NCT00069940   Information provided by National Cancer Institute (NCI)
First Received: October 3, 2003   Last Updated: February 6, 2009   History of Changes

October 3, 2003
February 6, 2009
December 2000
 
 
 
Complete list of historical versions of study NCT00069940 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
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.

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.

Phase I
Interventional
Treatment, Open Label
  • Brain and Central Nervous System Tumors
  • Gastrointestinal Stromal Tumor
  • Sarcoma
  • Biological: sargramostim
  • Biological: telomerase: 540-548 peptide vaccine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00069940
 
CDR0000301622, DFCI-02100
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: W. Nicholas Haining, BM, BCh Dana-Farber Cancer Institute
National Cancer Institute (NCI)
February 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP