M J O'Connell, R E Ritts, C G Moertel, J R O'Fallon, J Rubin, S Frytak, A J Schutt
{"title":"A controlled clinical and immunological evaluation of immunotherapy with Bacillus Calmette--Guerin in patients with metastatic cancer.","authors":"M J O'Connell, R E Ritts, C G Moertel, J R O'Fallon, J Rubin, S Frytak, A J Schutt","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>One hundred thirty adult patients with metastatic solid tumors were studied to evaluate the therapeutic results, toxicity, and immunological effects of three BCG preparations given intradermally by the multiple puncture time technique on either a monthly or weekly schedule: Tice lyophilized BCG, Pasteur lyophilized BCG, and Pasteur fresh-frozen BCG. Patients were randomly assigned in a double-blind manner to receive one of the BCG preparations or saline placebo administered in an identical manner. A battery of immunological tests were performed pretreatment and serially during the investigation. None of the 82 patients with measurable indicator lesions experienced an objective tumor response, nor were there any differences in survival among patients receiving any of the BCG preparations compared to placebo. Toxicity consisted of mild to moderate local cutaneous reactions and liver function abnormalities in BCG-treated patients with no significant differences between BCG preparations. Improvements in each of the assays of immune function performed occurred with roughly equal frequency among patients receiving BCG or placebo. It was not possible to demonstrate any significant clinical or immunological benefit from BCG administration in this patient population with the methodology employed.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 4","pages":"439-49"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17518047","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}
M De Lena, M Varini, R Zucali, D Rovini, G Viganotti, P Valagussa, U Veronesi, G Bonadonna
{"title":"Multimodal treatment for locally advanced breast cancer. Result of chemotherapy-radiotherapy versus chemotherapy-surgery.","authors":"M De Lena, M Varini, R Zucali, D Rovini, G Viganotti, P Valagussa, U Veronesi, G Bonadonna","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In a prospective randomized study, the efficacy of two combined modality approaches (chemotherapy plus radiotherapy or chemotherapy plus mastectomy) was tested in a total of 132 women with locally advanced breast cancer. Chemotherapy consisted of Adriamycin plus vincristine (AV) administered for three cycles before either local-regional modality and subsequently for seven additional cycles. Although a higher proportion of women achieved complete remission after mastectomy (100%) compared to women given radiotherapy (60%), the total response rate at the end of combined modality was identical (75%). There was no significant difference between the two treatment groups in terms of patterns of treatment failure, median duration of response, and total survival. Treatment was not influenced by menopausal or estrogen receptor status. Two patients of the surgical group showed Adriamycin-induced cardiomyopathy after cumulative doses less than 500 mg/m2. The results of present study failed to indicate that surgery per se improved the overall results including local control, over radiotherapy in a combined modality setting.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 3","pages":"229-36"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"18072611","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}
H Gilbert, A R Kagan, F Cassidy, J Wagner, K Fuchs, D Fox, I Macri, D Gilbert, A Rao, H Nussbaum, A Forsythe, J Eder, F Latino, L Youleles, P Chan, B L Hintz
{"title":"Glioblastoma multiforme is not a uniform disease!","authors":"H Gilbert, A R Kagan, F Cassidy, J Wagner, K Fuchs, D Fox, I Macri, D Gilbert, A Rao, H Nussbaum, A Forsythe, J Eder, F Latino, L Youleles, P Chan, B L Hintz","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 1","pages":"87-9"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17324198","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}
R T Eagan, R E Lee, S Frytak, M Scott, J N Ingle, E T Creagan, W C Nichols
{"title":"Thoracic radiation therapy and Adriamycin/cisplatin-containing chemotherapy for locally advanced non-small-cell lung cancer.","authors":"R T Eagan, R E Lee, S Frytak, M Scott, J N Ingle, E T Creagan, W C Nichols","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>One-hundred nine patients with limited-stage unresectable non-small-cell lung cancer were treated with Adriamycin--cisplatin-based combination chemotherapy and thoracic irradiation. Of this number, 73 received chemotherapy (one course) prior to irradiation and 37% (27/73) had tumor regression following chemotherapy alone. Sixty-eight percent of patients (73/107) experienced tumor regression following combined chemotherapy and irradiation. Age more than 65 years, a malignant ipsilateral pleural effusion, and no response to chemotherapy alone were all strong negative prognostic factors. Three-year survivals were as follows: all 109 patients, 14.0%; 89 patients without malignant pleural effusion, 17.0%; 71 patients with neither a malignant pleural effusion nor malignant ipsilateral supraclavicular adenopathy, 23.1%.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 4","pages":"381-8"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17337446","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}
D D Von Hoff, D S Alberts, D E Mattox, S Coulthard, B Dana, M Manning, J W Myers, C B Griffin
{"title":"Combination chemotherapy with cisplatin, bleomycin, and methotrexate in patients with advanced head and neck cancer.","authors":"D D Von Hoff, D S Alberts, D E Mattox, S Coulthard, B Dana, M Manning, J W Myers, C B Griffin","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Twenty-six patients with advanced head and neck cancer, 22 of whom had failed prior surgery and/or radiotherapy, were treated with a combination regimen of cis-diamminedichloroplatinum II, bleomycin, and methotrexate. There were no complete responses. Nine patients achieved a partial response (35%). Three of the four (75%) patients without prior therapy achieved a partial response while only 6 of the 22 patients (27%) with prior surgery and/or radiation therapy obtained a partial response. The median response duration was 3 months. Patients with a partial response did not live significantly longer than those who did not live significantly longer than those who did not respond. Toxic reactions were frequent: there were three episodes of sepsis secondary to leukopenia and two cases of bleomycin pulmonary toxicity. Mucositis was noted in 40% and nausea and vomiting in 60% of patients. We conclude that this triple-drug regimen has little value in the treatment of patients with advanced squamous cell carcinoma of the head and neck who have failed prior surgery and radiotherapy.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 2","pages":"215-8"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17232165","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}
{"title":"Palliation of liver metastases with combined hepatic irradiation and misonidazole. Results of a Radiation Therapy Oncology Group Phase I-II study.","authors":"S A Leibel, S E Order, C J Rominger, S O Asbell","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 3","pages":"285-93"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17234847","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}
{"title":"Clinical trials of misonidazole in the United States.","authors":"T H Wasserman, J Stetz, T L Phillips","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This paper presents a review of the progressive clinical trials of the hypoxic cell radiosensitizer, misonidazole, in the United States. Presentation is made of all of the schemata of the recently completed and currently active Radiation Therapy Oncology Group (RTOG) phase II and phase III studies. Detailed information is presented on the clinical toxicity of the phase I and II trials, specifically regarding neurotoxicity. With limitations in drug total dose, a variety of dose schedules have proven to be tolerable, with a moderate incidence of nausea and vomiting and mild peripheral neuropathy, and a low incidence of more severe peripheral neuropathy or central neuropathy. No other organ toxicity has been seen, specifically no liver, renal, or bone marrow toxicities. The clinical pharmacologic monitoring of misonidazole blood levels has been satisfactory with good correlation between the group-wide (phase II) UV values and the HPLC values from the phase I study. The patient accrual of the trials has been rapidly increasing and an early analysis suggests efficacy which is at least comparable to previous radiation experience. A series of the five phase III trials are currently underway in the RTOG and the results of these are pending. An additional malignant glioma trial in the Brain Tumor Study Group is described.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 1","pages":"7-16"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"18227813","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}
Z A Arlin, N Flomenberg, T S Gee, S J Kempin, C Dellaquila, R Mertelsmann, D J Straus, C W Young, B D Clarkson
{"title":"Treatment of acute leukemia in relapse with 4'(9-acridinylamino) methanesulfon-m-anisidide (AMSA) in combination with cytosine arabinoside and thioguanine.","authors":"Z A Arlin, N Flomenberg, T S Gee, S J Kempin, C Dellaquila, R Mertelsmann, D J Straus, C W Young, B D Clarkson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Thirty-seven patients with acute leukemia in relapse were treated with a three-drug combination that included a 3- or 4-day course of AMSA with total doses ranging from 600 mg/m2 to 740 mg/m2 I.V., cytosine arabinoside 25 mg/m2 I.V. followed by 200 mg/m2 by continuous infusion daily for 5 days, and thioguanine 100 mg/m2 p.o. q 12h for 5 days. Eight of the 25 patients with acute nonlymphoblastic leukemia achieved a complete remission and 3 a partial remission. None of the five patients with acute lymphoblastic leukemia achieved a response and there was one partial remission in the seven patients with myelodysplastic syndrome or blastic CML. Reversible toxicity included nausea and vomiting (78%), alopecia (100%), pancytopenia (100%), mild stomatitis (63%), and hepatic dysfunction (24%). One patient developed seizures and cardiac arrhythmias. The activity of this combination in heavily treated patients with ANLL is comparable to that of the anthracycline-containing regimens, and its use in previously untreated patients with ANLL should now be explored.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 3","pages":"317-21"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17944208","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}
{"title":"Combination chemoimmunotherapy for advanced renal carcinoma with Adriamycin, bleomycin, vincristine, cyclophosphamide, plus BCG.","authors":"B W Dana, D S Alberts","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Fourteen patients with advanced renal carcinoma were treated with Adriamycin 40 mg/m2 I.V., bleomycin 15 U/m2 I.V., vincristine 2 mg I.V., cyclophosphamide 200 mg/m2 p.o. x 4 days, and BCG by scarification every 4 weeks. Of 13 evaluable patients, three (23%) achieved partial remissions on therapy, five (39%) were improved, and three were stable. Responding disease sites included lung and pleural metastases, and an abdominal mass. Median duration of response was 4 months. Median survival was 8.5 months, but the partial responders survived for 13, 17, and 19 months. Toxicity included nausea and vomiting (31%), leukopenia (8%), thrombocytopenia (8%), diarrhea (15%), alopecia (8%), stomatitis (8%), and paresthesias (8%). This well-tolerated stomatitis (8%), and paresthesias (8%). This well-tolerated chemoimmunotherapy regimen has moderate activity in renal carcinoma and deserves further evaluation.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 2","pages":"205-7"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17232164","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}
{"title":"Differential protection against cytotoxic chemotherapeutic effects on bone marrow CFUs by Wr-2721.","authors":"T H Wasserman, T L Phillips, G Ross, L J Kane","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This paper reports on the ability of the radioprotector WR-2721 to protect bone marrow colony forming units from the cell kill of various cytotoxic chemotherapy agents including nitrogen mustard, cyclophosphamide, BCNU, cis-platinum, and 5-fluorouracil. The dose-modifying factors seen with these compounds ranged from 1.5 to 4.6. Protection by WR-2721 seems to be selective for the bone marrow endpoint, in that similar protection against EMT6/SF tumor cell kill was not seen with the same combination of the cytotoxic chemotherapy agents and WR-2721 as measured by regrowth delay. The implications of these data are discussed in the paper.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 1","pages":"3-6"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17324197","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}