Cancer clinical trials最新文献_第7页

Phase II trial of methylglyoxal-bis-(guanylhydrazone) in non-small-cell lung cancer. 甲基乙二醛-双-(鸟酰腙)治疗非小细胞肺癌的II期试验。

Cancer clinical trials Pub Date : 1981-01-01

R Chapman, D Kelsen, R Gralla, L Itri, E Casper, C Young, R Golbey

引用次数: 0

Animal toxicology for early clinical trials with anticancer agents. 抗癌药物早期临床试验的动物毒理学。

Cancer clinical trials Pub Date : 1981-01-01

M Rozencweig, D D Von Hoff, M J Staquet, P S Schein, J S Penta, A Goldin, F M Muggia, E J Freireich, V T DeVita

{"title":"Animal toxicology for early clinical trials with anticancer agents.","authors":"M Rozencweig, D D Von Hoff, M J Staquet, P S Schein, J S Penta, A Goldin, F M Muggia, E J Freireich, V T DeVita","doi":"","DOIUrl":"","url":null,"abstract":"This analysis was carried out to assess quantitative and qualitative relationships between animal and human toxicology data with anticancer drugs. Among 21 chemotherapeutic agents, one-sixth LD10 in the mouse or one-third toxic dose low (TDL) in the dog corresponded to acceptable doses in man when experimental and clinical data were obtained at identical schedules and compared on a mg/m2 basis. The mouse and the dog largely differed in their tolerance to individual drugs. One-tenth LD10 in the mouse seemed always tolerated in the dog. On the average, these species were equally relevant for establishing the initial dose in man. A similar number of dose escalation steps would have been required in phase I clinical trials if the starting dose had been based on one-tenth LD10 in the mouse or the lowest value of one-sixth LD10 in the mouse and one-third TDL in the dog. These observations indicate that the starting dose in phase I clinical trials could be safely and efficiently based on one-tenth LD10 in the mouse. Prior verification that the resulting dose is not lethal or life-threatening in the dog could add further safety to this procedure. The predictive value (PV+) in man of organ system toxicity in animals depends upon the prevalence of this toxicity in man. In our study, PV+ was high (greater than 0.85) for common toxic effects in man, i.e., gastrointestinal intolerance and myelosuppression. PV+ declined dramatically (0.05 to 0.54) with rarer toxic manifestations. There was no clear superiority of animal findings over the mere knowledge of the prevalence of these findings in man. Thus, it would appear that routine and undiscerned investigation of organ system toxicity in animals is of questionable usefulness for the clinician experienced in early clinical trials with chemotherapeutic agents.","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 1","pages":"21-8"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17835003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Pulmonary section - cardiorespiratory workshop. 肺切片-心肺车间。

Cancer clinical trials Pub Date : 1981-01-01

T Phillips

引用次数: 0

Statistical inference in the analysis of radiation compliance and its relation to treatment outcome. 放射依从性分析的统计推断及其与治疗结果的关系。

Cancer clinical trials Pub Date : 1981-01-01

R A Potish, J Boen, S H Levitt

引用次数: 0

Optimization of radiotherapy. Some notes on the principles and practice of optimization in cancer treatment and implications for clinical research. 放疗优化。关于肿瘤治疗最优化的原则和实践及其对临床研究的启示。

Cancer clinical trials Pub Date : 1981-01-01

J R Andrews

{"title":"Optimization of radiotherapy. Some notes on the principles and practice of optimization in cancer treatment and implications for clinical research.","authors":"J R Andrews","doi":"","DOIUrl":"","url":null,"abstract":"Two methods dominate cancer treatment--one, the traditional best practice, individualized treatment method and two, the a priori determined decision method of the interinstitutional, cooperative, clinical trial. In the first, choices are infinite and can be made at the time of treatment; in the second, choices are finite and are made in advance of treatment on a random basis. Neither method systematically selects, identifies, or formalizes the optimum level of effect in the treatment chosen. Of the two, it can be argued that the first, other things being equal, is more likely to select the optimum treatment. The determination of level of effect for the optimization of cancer treatment requires the generation of dose-response relationships for both benefit and risk and the introduction of benefit and risk considerations and judgements. The clinical trial, as presently constituted, doses not yield this kind of information, it being, generally, of the binary yes or no, better or worse type. The best practice, individualized treatment method can yield, when adequately documented, both a range of dose-response relationships and a variety of benefit and risk considerations. The presentation will be limited to a consideration of a single modality of cancer treatment, radiation therapy, but an analogy with other modalities of cancer treatment will be inferred. Criteria for optimization will be developed and graphic means for its identification and formalization will be demonstrated with examples taken from the radiotherapy literature. The general problem of optimization theory and practice will be discussed; the necessity for its exploration in relation to the increasing complexity of cancer treatment will be developed; and recommendations for clinical research will be made including a proposal for the support of clinics as an alternative to the support of programs.","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 4","pages":"483-95"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"18330815","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Acivicin. An antitumor antibiotic. Acivicin。抗肿瘤抗生素。

Cancer clinical trials Pub Date : 1981-01-01

D S Poster, S Bruno, J Penta, G L Neil, J P McGovren

{"title":"Acivicin. An antitumor antibiotic.","authors":"D S Poster, S Bruno, J Penta, G L Neil, J P McGovren","doi":"","DOIUrl":"","url":null,"abstract":"Acivicin [(alpha S,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazoleacetic acid; AT-125; NSC-163501] is a fermentation product of Streptomyces sviceus which is active in a variety of mouse tumor models including the L1210 and P388 leukemias, the M5076 ovarian carcinoma, and the MX-1 human breast tumor xenograft. Antitumor activity is probably mediated through the inhibition of enzymes catalyzing amido transfer from L-glutamine, especially CTP synthetase and XMP aminase. In mice, acivicin is absorbed systemically via the p.o., I.P., and S.C. routes and is predominantly excreted in the urine in unchanged form. Although a wide variety of toxicities, including myelosuppression, were noted in dogs and monkeys, vomiting, diarrhea, and pathologic lesions of the GI tract predominated in both species. A marked cumulative toxicity was noted in dogs with 16 mg/m2/day being the lethal dose on the daily x 5 schedule compared to 1000 mg/m2 on the single-dose schedule. An interesting phenomenon was noted in mice wherein older male mice were more resistant to the toxic effects of the drug than female or younger male mice. This sex and age difference in susceptibility to acivicin toxicity was shown to be correlated with differences in pharmacokinetics; older male mice cleared acivicin at approximately twice the rate of females or younger males. No sex differences in toxicity were noted in dogs or monkeys. Because of its activity in mouse tumor systems and acceptable preclinical toxicology patterns, the drug is being introduced into clinical phase I studies under the sponsorship of the National Cancer Institute.","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 3","pages":"327-30"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"18072616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A five-drug combination in the treatment of metastatic breast cancer. 五药联合治疗转移性乳腺癌。

Cancer clinical trials Pub Date : 1981-01-01

G Falkson, H C Falkson

引用次数: 0

Evaluation of beta-2'-deoxythioguanosine combined with methyl-CCNU or mitomycin in advanced colorectal cancer. A Southwest Oncology Group study. β -2′-脱氧硫代鸟苷联合甲基- ccnu或丝裂霉素治疗晚期结直肠癌的疗效评价。西南肿瘤小组的一项研究。

Cancer clinical trials Pub Date : 1981-01-01

R G Gagliano, F J Panettiere, C D Haas, L Baker, J Hewlett, W J Stuckey, R M O'Bryan, R Bottomley, L K Heilburn

引用次数: 0

Microscopic disease. 微观的疾病。

Cancer clinical trials Pub Date : 1981-01-01

H Nussbaum