Source:http://linkedlifedata.com/resource/pubmed/id/11420638
Switch to
| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
10
|
| pubmed:dateCreated |
2001-6-22
|
| pubmed:abstractText |
Although genetically engineered adenoviruses hold promise for the treatment of cancer, clinical trial reports have utilized intratumoral injection to date. To determine the feasibility of intravenous delivery of ONYX-015, an E1B-55kD gene-deleted replication selective adenovirus with demonstrated clinical safety and antitumoral activity following intratumoral injection, we performed a clinical trial in patients with metastatic solid tumors. ONYX-015 was infused intravenously at escalating doses of 2 x 10(10) to 2 x 10(13) particles via weekly infusion within 21-day cycles in 10 patients with advanced carcinoma metastatic to the lung. No dose-limiting toxicity was identified. Mild to moderate fever, rigors and a dose-dependent transient transaminitis were the most common adverse events. Neutralizing antibody titers significantly increased within 3 weeks in all patients. IL-6, gamma-IFN, TNF-alpha and IL-10 increased within 24 h following treatment. Evidence of viral replication was detectable in three of four patients receiving ONYX-015 at doses > or = 2 x 10(12) particles and intratumoral replication was confirmed in one patient. In conclusion, intravenous infusion of ONYX-015 was well tolerated at doses up to 2 x 10(13) particles and infection of metastatic pulmonary sites with subsequent intratumoral viral replication was seen. The intravenous administration of genetically altered adenovirus is a feasible approach.
|
| pubmed:language |
eng
|
| pubmed:journal | |
| pubmed:citationSubset |
IM
|
| pubmed:chemical | |
| pubmed:status |
MEDLINE
|
| pubmed:month |
May
|
| pubmed:issn |
0969-7128
|
| pubmed:author | |
| pubmed:issnType |
Print
|
| pubmed:volume |
8
|
| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
Y
|
| pubmed:pagination |
746-59
|
| pubmed:dateRevised |
2006-4-24
|
| pubmed:meshHeading |
pubmed-meshheading:11420638-Adenocarcinoma,
pubmed-meshheading:11420638-Adenocarcinoma, Mucinous,
pubmed-meshheading:11420638-Adenoviridae,
pubmed-meshheading:11420638-Adrenal Gland Neoplasms,
pubmed-meshheading:11420638-Adult,
pubmed-meshheading:11420638-Aged,
pubmed-meshheading:11420638-Antineoplastic Combined Chemotherapy Protocols,
pubmed-meshheading:11420638-Carboplatin,
pubmed-meshheading:11420638-Carcinoma,
pubmed-meshheading:11420638-Carcinoma, Papillary,
pubmed-meshheading:11420638-Carcinoma, Squamous Cell,
pubmed-meshheading:11420638-Colonic Neoplasms,
pubmed-meshheading:11420638-Feasibility Studies,
pubmed-meshheading:11420638-Female,
pubmed-meshheading:11420638-Gene Therapy,
pubmed-meshheading:11420638-Genetic Vectors,
pubmed-meshheading:11420638-Head and Neck Neoplasms,
pubmed-meshheading:11420638-Humans,
pubmed-meshheading:11420638-Infusions, Intravenous,
pubmed-meshheading:11420638-Lung Neoplasms,
pubmed-meshheading:11420638-Male,
pubmed-meshheading:11420638-Middle Aged,
pubmed-meshheading:11420638-Osteosarcoma,
pubmed-meshheading:11420638-Paclitaxel,
pubmed-meshheading:11420638-Thyroid Neoplasms
|
| pubmed:year |
2001
|
| pubmed:articleTitle |
Intravenous infusion of a replication-selective adenovirus (ONYX-015) in cancer patients: safety, feasibility and biological activity.
|
| pubmed:affiliation |
US Oncology, Dallas, TX 75246, USA.
|
| pubmed:publicationType |
Journal Article,
Clinical Trial,
Clinical Trial, Phase I
|