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OpenTrials
Completed

NCT Number: NCT00069940

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sargramostim

Biological

telomerase: 540-548 peptide vaccine

Biological

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF

Important dates

Study start
2000
Primary completion
2006
Study completion
2008
First posted
Oct 7, 2003
Registry last updated
Dec 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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