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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 2 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00069940
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Dana-Farber Cancer Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 W. Nicholas Haining, BM, BCh
Principal Investigator Affiliation Dana-Farber Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors, Gastrointestinal Stromal Tumor, Sarcoma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston, Massachusetts

Status

Address

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115

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