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

December 26, 2010 updated by: Dana-Farber Cancer Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: W. Nicholas Haining, BM, BCh, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

October 3, 2003

First Submitted That Met QC Criteria

October 6, 2003

First Posted (Estimate)

October 7, 2003

Study Record Updates

Last Update Posted (Estimate)

December 28, 2010

Last Update Submitted That Met QC Criteria

December 26, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-365
  • P30CA006516 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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