Linked Life Data

12396624

Source:http://linkedlifedata.com/resource/pubmed/id/12396624

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
14
pubmed:dateCreated
2002-10-24
pubmed:abstractText
The primary objective of this phase I study was to determine the safety of an autologous tumor vaccine given by intradermal injection of lethally irradiated granulocyte-macrophage colony-stimulating factor (GM-CSF) gene-transfected autologous melanoma and sarcoma cells. Secondary objectives included validation of the gene delivery technology (particle-mediated gene transfer), determining the host immune response to the tumor after vaccination, and monitoring patients for evidence of antitumor response. Sixteen patients were treated with either of two different doses of GM-CSF-treated tumor cells. One patient received treatment with both doses of tumor cells. No treatment-related local or systemic toxicity was noted in any patient. Patients administered 100% treated cells (i.e., with a preparation of tumor cells that had all been exposed to GM-CSF DNA transfection) had a more extensive lymphocytic infiltrate at the vaccine site than did patients given 10% treated cells (a preparation of tumor cells in which 10% had been exposed to GM-CSF transfection) or nontreated tumor. The generation of a systemic immune response to autologous tumor by a delayed-type hypersensitivity response to the intradermal placement of nontransfected tumor cells was noted in one patient. One patient had a transient partial response of metastatic tumor sites. The entire procedure, from tumor removal to vaccine placement, was accomplished in less than 6 hr in all patients. Four of 17 patient tumor preparations produced greater than 3.0 ng of GM-CSF per 10(6) cells per 24 hr in vitro. The one patient with greater than 30 ng of GM-CSF per 10(6) cells per 24 hr in vitro had positive DTH, a significant histologic inflammatory response, and clinically stable disease. This technique of gene transfer was safe and feasible, but resulted in clinically relevant levels of gene expression in only a minority of patients.
pubmed:grant
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Sep
pubmed:issn
1043-0342
pubmed:author
pubmed:issnType
Print
pubmed:day
20
pubmed:volume
13
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1711-21
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed-meshheading:12396624-Biolistics, pubmed-meshheading:12396624-Cancer Vaccines, pubmed-meshheading:12396624-DNA, Complementary, pubmed-meshheading:12396624-Dose-Response Relationship, Immunologic, pubmed-meshheading:12396624-Feasibility Studies, pubmed-meshheading:12396624-Gold, pubmed-meshheading:12396624-Granulocyte-Macrophage Colony-Stimulating Factor, pubmed-meshheading:12396624-Humans, pubmed-meshheading:12396624-Hypersensitivity, Delayed, pubmed-meshheading:12396624-Immunologic Factors, pubmed-meshheading:12396624-Injections, Intradermal, pubmed-meshheading:12396624-Leiomyosarcoma, pubmed-meshheading:12396624-Liposarcoma, pubmed-meshheading:12396624-Melanoma, pubmed-meshheading:12396624-Safety, pubmed-meshheading:12396624-Sarcoma, pubmed-meshheading:12396624-Soft Tissue Neoplasms, pubmed-meshheading:12396624-Treatment Outcome, pubmed-meshheading:12396624-Tumor Cells, Cultured, pubmed-meshheading:12396624-Vaccines, DNA
pubmed:year
2002
pubmed:articleTitle
Immunization by particle-mediated transfer of the granulocyte-macrophage colony-stimulating factor gene into autologous tumor cells in melanoma or sarcoma patients: report of a phase I/IB study.
pubmed:affiliation
Department of Surgery, University of Wisconsin School of Medicine, Madison, WI 53792, USA. mahvi@surgery.wisc.edu
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, U.S. Gov't, P.H.S., Research Support, Non-U.S. Gov't, Clinical Trial, Phase I