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Phase I trial of r viscumin (INN: aviscumine) given subcutaneously in patients with advanced cancer: a study of the European Organisation for Research and Treatment of Cancer (EORTC protocol number 13001).
- Source :
-
European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2008 Aug; Vol. 44 (12), pp. 1657-62. Date of Electronic Publication: 2008 Jul 02. - Publication Year :
- 2008
-
Abstract
- Safety of aviscumine by subcutaneous route was assessed in patients with advanced cancer refractory to chemotherapy. Patients with progressive disease received escalating doses twice weekly. Treatment of the accrued 26 patients (10 colorectal cancer (CRC), 6 soft tissue sarcoma (STS), 5 melanoma (MM), 5 others) was well tolerated without substance-related grade 3 or 4 toxicities. Grade 1/2 toxicities were predominantly injection site reactions. Aviscumine lacked dose-limiting toxicity (DLT) up to a maximal dose of 10 ng/kg. An increase of interleukin-1 beta and interferon-gamma from baseline was seen in the patient's plasma between the 1st and 11th injection. Highest release of both cytokines was in the dose range of 4-5.9 ng/kg. Interferon-gamma was not detected after doses higher than 6 ng/kg. Eight patients (5 CRC, 1 MM, 1 STS, 1 RCC) had disease stabilisation for 79-250 days (median122 days) associated with an increase of interleukin (IL)-1 beta and interferon (IFN)-gamma. Aviscumine was well tolerated and appeared to possess clinical activity at a biologically active dose between 4 and 6 ng/kg.
- Subjects :
- Adjuvants, Immunologic adverse effects
Adjuvants, Immunologic pharmacokinetics
Administration, Cutaneous
Adult
Aged
Antibodies, Neoplasm metabolism
Antineoplastic Agents, Phytogenic adverse effects
Antineoplastic Agents, Phytogenic pharmacokinetics
Dose-Response Relationship, Immunologic
Female
Humans
Infusions, Intravenous
Male
Maximum Tolerated Dose
Middle Aged
Plant Preparations adverse effects
Plant Preparations pharmacokinetics
Ribosome Inactivating Proteins, Type 2 adverse effects
Ribosome Inactivating Proteins, Type 2 pharmacokinetics
Toxins, Biological adverse effects
Toxins, Biological pharmacokinetics
Treatment Outcome
Adjuvants, Immunologic administration & dosage
Antineoplastic Agents, Phytogenic administration & dosage
Neoplasms drug therapy
Plant Preparations administration & dosage
Ribosome Inactivating Proteins, Type 2 administration & dosage
Toxins, Biological administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1879-0852
- Volume :
- 44
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- European journal of cancer (Oxford, England : 1990)
- Publication Type :
- Academic Journal
- Accession number :
- 18602257
- Full Text :
- https://doi.org/10.1016/j.ejca.2008.05.005