Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00069940
First received: October 3, 2003
Last updated: December 26, 2010
Last verified: December 2010
  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
Biological: sargramostim
Biological: telomerase: 540-548 peptide vaccine
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Study Start Date: December 2000
Study Completion Date: August 2008
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: William Haining, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00069940     History of Changes
Other Study ID Numbers: 03-365, P30CA006516
Study First Received: October 3, 2003
Last Updated: December 26, 2010
Health Authority: United States: Federal Government

Keywords provided by Dana-Farber Cancer Institute:
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

Additional relevant MeSH terms:
Sarcoma
Gastrointestinal Stromal Tumors
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014