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TA-33. PRELIMINARY PHASE I TRIAL RESULTS: PTK787 ZK 222584 PTK ZK ; , AN ORAL VEGF TYROSINE KINASE INHIBITOR, IN COMBINATION WITH EITHER TEMOZOLOMIDE OR LOMUSTINE FOR PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME GBM ; D. Reardon, 1 H. Friedman, 1 W. Yung, 2 M. Brada, 3 C. Conrad, 2 J. Provenzale, 1 E. Jackson, 2 H. Serajuddin, 4 D. Laurent, 5 and D. Reitsma4; 1 Duke University Medical Center, Durham, NC, USA; 2University of Texas M.D. Anderson Cancer Center, Houston, TX; USA; 3Royal Marsden NHS Trust, Surrey, England, UK; 4Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 5Schering AG, Berlin, Germany Vascular endothelial growth factor VEGF ; -mediated signaling is integral to GBM neovascularization and therefore is an attractive therapeutic target. PTK787 ZK 222584 PTK ZK ; is a novel oral angiogenesis inhibitor that potently inhibits VEGFR tyrosine kinases, important receptors in the formation of the new blood vessels that contribute to tumor growth and metastasis. The primary objective of this trial was to determine the safety profile and maximum tolerated dose MTD ; of PTK ZK using continuous daily dosing in combination with either temozolomide TMZ ; or lomustine CCNU ; in patients with GBM. Secondary objective was to evaluate pharmacokinetic interactions and antitumor activity. Using a 3 + 3, phase I, dose-escalation design, the starting dose of PTK ZK was 500 mg day, escalated to 1000 mg, 1250 mg, and 1500 mg day in cohorts of 3 to patients. Concurrently, patients also received either TMZ 200 mg m2 day for 5 days every 28 days ; or CCNU 130 mg m2 every 6 weeks ; . To date, 21 evaluable patients have been treated with PTK ZK and TMZ at the 500- n 6 ; , 1000- n 6 ; , 1250 n 3 ; , and 1500-mg n 6 ; dose levels. Only 1 dose-limiting toxicity DLT ; occurred grade 3 dizziness in a patient treated at the 1500-mg dose level ; . Best response includes 2 partial responses PR ; at 1250 and 1500 mg day each and stable disease SD ; in 9 patients treated with TMZ plus PTK ZK. Accrual has been expanded at the 1500-mg PTK ZK dose level, and 9 additional patients have been enrolled. Although it is too early to assess response in most of these patients, 1 patient treated at 1500 mg day in the expansion phase achieved a PR. Fourteen evaluable patients have been treated with PTK ZK plus CCNU at the 500- n 5 ; , 750- n 3 ; , and 1000-mg n 6 ; dose levels. In these patients, DLTs included grade 3 fever neutropenia in 1 patient each at the 500- and 1000-mg levels, and grade 4 transaminase ele.
Adapalene pillsHas now established that migrating birds are the primary influenza reservoir, with subsequent transfer to other hosts domestic birds, pigs, etc., and humans. An example is an outbreak in Holland in 2003, in which surveillance of migrating birds picked up a H7N7 influenza variant which was spreading to domestic chickens, and into the human population. As a measure to thwart the virus spread, some 30 million chickens were culled, while infected humans were treated with Tamiflu. One human death resulted. Other examples occurred in the UK in 1996; in Hong Kong in 1997; in Thailand and Vietnam in 2004 2005. A large pandemic will probably occur, and we are urged to become better prepared, with stockpiles of anti-influenza drugs, and available vaccines. Malakhov et al., Abst. 20 provided the development of an interesting concept of eliminating sialic acid receptors for influenza and parainfluenza viruses by use of a recombinant fusion protein, Fludase. Fludase is stable and inexpensive, is not inactivated by mucous, and has low immunogenicity. Fludase tethers to the respiratory epithelium, reducing the available receptors needed for virus spread. Clinical research is expected in 2006. Neuman et al., Abst. 23 have identified peptide-conjugated antisense morpholino 18 to 21 base olignucleotides targeted to the SARS coronavirus RNA sequences required for gene expression. The antisense compounds are highly sequence-specific and potent antivirals at 5 uM cell culture, and similar oligonucleotides against the related coronavirus, murine hepatitis virus showed efficacy against mouse infection. Alvarez et al., Abst LB-15 used 21 to 23 nucleotide double-stranded siRNAs at 5 nM demonstrate sequence-specific cleavage of RSV P gene mRNA in cell culture studies. Intranasal application of 50 ug the anti-RSV siRNA reduced lung RSV load in BALB c mice, if siRNA was applied within two days post-infection. Sidwell et al., Abst. 123 demostrated that Barrogen, a potent protein immunostimulant identified as an anti-tumor agent in mice and man, has anti-influenza A and B activity in mouse efficacy studies when administered either ip or intranasally at 10 ug less. Barrogen was not toxic at 500 ug. Efficacy was improved further by co-administration with granulated macrophage colony stimulating factor GM-CSF ; . This is an exciting observation that will be further investigated. Lastly, Barak and Ovadia, Abst. 129 demonstrated that crude cinnamon extract administrated with influenza virus inhibited virus replication cell cultures and appeared protective in mouse infections, for example, collagen. 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Dr. Shalita presented data illustrating the markedly greater reduction in both inflammatory and noninflammatory lesions when agents are used together rather than alone. They can be used simultaneously or alternated, and ideally a retinoid should be added. Owing to the low survival rate of the animals in this group. Animal weight in the 0.2 g and 0.3 g dose groups at the end of the study was found to be significantly different from that in controls Table ; . When compared with baseline animal weights at the start of treatment, the control animals had an average weight gain of 12.43%, the 0.1 g group had an average gain of 9.68%, the 0.2 g group had an average gain of 2.43%, the 0.3 g group had an average weight loss of 5.70%, and the 0.6 g group had an average loss of 4.99%. Of note, tumor size, tumor volume, and tumor weight were not significantly different between the 0.2 g and 0.3 g groups P .41, P .44, and P .41, respectively ; , whereas animal weight was different between those groups at P .002. KIDNEY CALCIFICATION Kidneys were harvested and histologically processed from 15 mice in the control group, 6 mice each in the 0.1 g and 0.2 g groups, 12 mice in the 0.3 g group, 9 mice in the 0.6 g group, and 3 mice in the 1.2 g group. One and aldara. To assess the importance of mitotane treatment, the blood levels will be correlated to clinical response. Therefore, mitotane plasma serum levels will be measured at least every four weeks in the first 6 months of administration and later every 8 weeks in one of the reference laboratories see Appendix 6, page 81 ; . Blood has to be drawn in the morning at least 12 hours after administration the last tablet. 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To whom correspondence should be addressed. Division of Nephrology, Department of Internal Medicine, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa City, IA 52242-1081. Tel: 319-356-4216 Fax: 319-356-2999 E-mail: christie-thomas uiowa, for example, differin adapalend gel.
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