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  • 11
    Electronic Resource
    Electronic Resource
    Clinical pharmacology of the anticancer polypeptide neocarzinostatin (1983)
    Springer
    Cancer chemotherapy and pharmacology 10 (1983), S. 200-204 
    Details
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary The clinical pharmacology of the anticancer polypeptide neocarzinostatin was studied in 16 patients with disseminated neoplasia using a radioimmunoassay technique. Patients who received 2,400–3,600 U of the drug per square meter BSA by rapid IV infusion had triphasic plasma decay curves. For eight patients with normal hepatic and renal function, neocarzinostatin mean plasma half-lives were 0.14, 0.50, and 7.7h. The mean plasma drug clearance was 32.4 ml/min/m2 and the apparent volume of distribution 19.3l/m2. Two patients with liver dysfunction had shorter terminal plasma half-lives and greater drug clearances, while two with renal disease exhibited prolonged plasma half-lives and reduced drug clearances. The mean cumulative urinary excretion of neocarzinostatin was 69.1% of the administered dose at 72 h in three patients with normal hepatic and renal function. One patient with liver disease excreted 90.4%, while a patient with renal disease excreted only 58.1% of the dose in 24 h. In one patient with marked liver disease, biliary excretion accounted for 0.1% of the administered dose in 72 h. Cerebrospinal fluid concentrations of neocarzinostatin studied in two patients showed a CSF penetration of about 16% the plasma concentration at 1–5 h; concentrations persisted for 19 h in one patient with an Omayha reservoir. Neocarzinostatin was rapidly cleared from the plasma and eliminated in the urine. Dosage reductions of 50% are recommended for patients with impaired renal function, while no reduction or escalated doses could be tolerated by patients with liver disease. The pharmacologic data suggest a continuous IV infusion may be a more toxic but perhaps more effective schedule of administration.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00255763
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  • 12
    Electronic Resource
    Electronic Resource
    Clinical, toxicological, and pharmacological studies of combination chemotherapy of adenocarcinoma with Adriamycin and Baker's Antifolate (1978)
    Springer
    Cancer chemotherapy and pharmacology 1 (1978), S. 139-144 
    Details
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Ten patients with disseminated adenocarcinoma were treated with combination chemotherapy employing Adriamycin and Baker's Antifolate (BAF). There were seven patients with lung adenocarcinoma, two of whom achieved partial remission while the remaining five had their disease stabilized. Drug toxicity to the bone marrow, gastrointestinal mucosa, and skin was dose-limiting and was greater than the known toxicities of the individual drugs. Pharmacological studies of both drugs were performed on five patients to determine whether abnormal pharmacokinetics could explain this collateral toxicity. Adriamycin plasma concentrations and disappearance seemed to be unaffected by BAF. However, BAF levels were prolonged, apparently due to an Adriamycin effect on the plasma elimination of BAF, resulting in a prolonged exposure of sensitive tissues and organs to BAF. Consequently, when BAF and Adriamycin are used in combination, appropriate dose and schedule changes must be made to avoid any potentially serious side effects.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00253114
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  • 13
    Electronic Resource
    Electronic Resource
    Evaluation of mitoxantrone cardiac toxicity by nuclear angiography and endomyocardial biopsy: an update (1985)
    Springer
    Investigational new drugs 3 (1985), S. 117-121 
    Details
    ISSN: 1573-0646
    Keywords: mitoxantrone ; cardiotoxicity ; angiography ; endomyocardial biopsy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Sixty-six patients who underwent endomyocardial biopsy for detection of mitoxantrone (Novantrone®; dihydroxyanthracenedione) cardiac toxicity were evaluated. All but one had breast cancer, 29 had received prior doxorubicin and 29 of the 37 patients who had not had prior doxorubicin received it or another anthracycline subsequently. Endomyocardial biopsy was carried out initially after four courses of chemotherapy with increasing intervals thereafter. Although cardiac ejection fraction was determined before each course of chemotherapy, our data are limited to cardiac ejection fractions from our own institution which were repeated approximately every four courses. Endomyocardial biopsy changes consisting of dilatation of the sarcoplasmic reticulum with vacuole formation, and myofibrillar dropout are similar to the early changes of anthracycline cardiomyopathy. While there was a slight suggestion of increasing biopsy grade with increasing mitoxantrone dose, no significant changes in cardiac ejection fraction could be associated, regardless of prior doxorubicin therapy. We concluded that mitoxantrone does show morphologic evidence of cardiac toxicity; however, the structural changes are minor and are haemodynamically insignificant. Determination of how much mitoxantrone treatment may contribute to the deterioration of pre-existing doxorubicin damage must await the outcome of longer follow-up.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00174158
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  • 14
    Electronic Resource
    Electronic Resource
    Phase II study of AMSA alone and in combination with DTIC in patients with metastatic melanoma (1988)
    Springer
    Investigational new drugs 6 (1988), S. 57-61 
    Details
    ISSN: 1573-0646
    Keywords: AMSA ; DTIC ; metastatic melanoma ; chemotherapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary A randomized phase II study of AMSA (amsacrine) alone and AMSA combined with DTIC (dacarbazine) was carried out in 31 and 39 patients with metastatic melanoma respectively. AMSA was used at a starting dose of 40 mg/m2/day × 3 days with escalation to 50–60 mg/m2/day × 3 days in 8 pts. For AMSA + DTIC the starting dose was: AMSA 30 mg/m2/day × 3 days; DTIC, 800 mg/m2 × 1 day. Additionally, seven pts received AMSA in a similar dose schedule but DTIC was used in a 5-day schedule of 250 mg/m2/day. Twentyfive patients were evaluable for response in the AMSA group and 36 in the AMSA + DTIC group. The objective response to AMSA included 1(4%) partial response compared with 11 complete or partial responses (30%) with AMSA + DTIC therapy. The median lowest absolute granulocyte count was 1100/μl in AMSA group compared with 1000/μl in the AMSA + DTIC group. Severe neutropenia of 〈 500 granulocytes/μl was observed in 5 pts in the AMSA group compared with 13 pts in the AMSA + DTIC group. We concluded that AMSA has no significant activity against melanoma, although the combination of AMSA + DTIC seemed to be more active than DTIC alone.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00170782
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  • 15
    Electronic Resource
    Electronic Resource
    Intracerebral penetration and tissue distribution of 2,5-diaziridinyl 3,6-bis(carboethoxyamino) 1,4-benzoquinone (AZQ, NSC-182986) (1983)
    Springer
    Journal of neuro-oncology 1 (1983), S. 15-19 
    Details
    ISSN: 1573-7373
    Keywords: intracerebral tumor ; CSF ; AZQ
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract [14C]AZQ (2–4 mg/m2, 100–200 mCi) was administered at varying times to five patients undergoing surgical resection of intracerebral tumors. Plasma, cerebrospinal fluid (CSF), edematous brain, and tumor specimens were obtained during surgery and the concentration of AZQ was determined radiochemically and chromatographically. Total [14C]AZQ equivalent concentration in tumor for two patients was determined to be 47.5% and 85% of concurrent plasma concentration which was similar to that found in normal brain (60.4% and 75.5% respectively). Only 18–45% of the total radioactivity in tumor tissue and 30–56% in plasma were accounted for by unchanged AZQ. These findings suggest that AZQ may be metabolized to a certain extent. Tissue samples from various organs were obtained during autopsy in a patient who expired ten days after AZQ administration. The highest AZQ concentration was found in the liver, followed by the kidney. Comparable amounts were found in normal brain and brain tumor (22 ng/ g vs. 31 ng/ g respectively). These results indicate that AZQ penetrates readily into the normal brain and brain tumor with a tendency to persist.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00153636
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  • 16
    Electronic Resource
    Electronic Resource
    A pilot study of cis-diamminedichloroplatinum and radiation therapy in patients with high grade astrocytomas (1983)
    Springer
    Journal of neuro-oncology 1 (1983), S. 109-113 
    Details
    ISSN: 1573-7373
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary A pilot study was performed combining cis-diamminedichloroplatinum (CDDP) and radiation therapy to treat patients with high-grade astrocytomas. CDDP at a dose of 40 mg/ m2/ week intravenously was given during the course of cranial irradiation. Following irradiation, CDDP was given every three weeks on a schedule of 35–40 mg/ m2/ day for three days until toxicity became unacceptable or until tumor progression occurred. Radiation therapy consisted of 6 000 rads over a seven week period or 5 000 rads followed by an additional 1500 rads to the tumor site. Patients were followed by computerized axial tomography (CT) scan and neurologic examination. Thirty patients were entered onto the study; 22 were considered evaluable. The median survival was 53 weeks and the median time to progression was 21 weeks. Toxicity was generally tolerable; however, ototoxicity may be enhanced by this treatment. CDDP combined with cranial irradiation is tolerable and feasible, although close follow-up is recommended in case CDDP has to be temporarily interrupted.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00182955
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  • 17
    Electronic Resource
    Electronic Resource
    Concentrations of vinblastine in human intracerebral tumor and other tissues (1983)
    Springer
    Journal of neuro-oncology 1 (1983), S. 139-144 
    Details
    ISSN: 1573-7373
    Keywords: vinblastine ; human brain tumors ; autopsy tissues ; CSF
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Uptake of vinblastine into human cerebrospinal fluid, intracerebral tumor and autopsy tissues was quantitated radiochemically after separating vinblastine from its metabolites by high pressure liquid chromatography. Only low concentrations of vinblastine were found in cerebrospinal fluid from a single patient. A second patient who received a tracer dose of radiolabelled vinblastine prior to surgical resection of an intracerebral tumor had slightly less radioactivity in tumor than in temporalis muscle, but more in tumor than in edematous brain surrounding the tumor. The radioactivity in tumor increased gradually and exceeded concurrent plasma radioactivity by 2 hr after drug administration. A third patient died 4 hr into a planned 24-hr infusion of radiolabeled vinblastine. Highest vinblastine concentrations were found in organs with high blood flow such as kidney and heart. Intermediate concentrations were found in liver and lung, and low concentrations were found in prostate, gastrointestinal tract, spleen, muscle, bladder, and hepatic and lymph node metastases. A fourth patient died one month after receiving radiolabeled vinblastine. Highest concentrations were in liver and next highest concentrations were in intracerebral tumor. Moderately high concentrations were found in pancreas, thyroid, lung, spleen, ovary, kidney, and kidney metastases. Lowest concentrations were found in omental metastases, heart, breast, and brain. Vinblastine concentration decreased with increasing distance into brain from the brain metastases. Thus, vinblastine was not selectively localized in tumors. The concentrations in tumor did not reflect the concentration in the organ in which the tumor was located. There was no indication that uptake into intracerebral tumor was impaired. Cerebrospinal fluid and brain concentrations of vinblastine did not give any indication of the concentration attainable in intracerebral tumor.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00182959
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  • 18
    Electronic Resource
    Electronic Resource
    Weekly Cisplatin during cranial irradiation for malignant melanoma metastatic to brain (1983)
    Springer
    Journal of neuro-oncology 1 (1983), S. 49-51 
    Details
    ISSN: 1573-7373
    Keywords: Cisplatin ; radiopotentiation ; melanoma ; intracerebral
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Because Cisplatin potentiates the effect of radiotherapy in animal tumor systems and because Cisplatin is capable of causing regressions of human malignant melanomas, a study was initiated in patients with malignant melanoma metastatic to brain to investigate the feasibility of administering Cisplatin once a week during cranial irradiation. Cisplatin 40 mg/m2/week (three doses) was given LV. to 18 patients during whole brain irradiation, 3 000 rads in 12 fractions over 2 1/2 weeks. Eleven patients also received Cisplatin 120 mg/m2 every three weeks, starting three weeks after cranial irradiation. Median survival was ten weeks, and only one of 13 patients whose brain metastases had not been resected experienced neurological and CT scan improvement. Thirteen patients have died, and brain metastases were a major cause. No regression of extracerebral tumor was seen in 15 patients with eveluable extracerebral lesions. During weekly low-dose Cisplatin administration, nausea and vomiting were moderate to severe. No granulocytopenia was noted, although three courses were associated with mild thrombocytopenia. Mucositis, peri orbital swelling, vertigo, and headache were each noted in two of 51 courses of treatment and seizures, ototoxicity, pancreatitis, and hiccups were each noted in one course. Renal toxicity and ototoxicity each developed in three of the 11 patients receiving Cisplatin 120 mg/ m2, and nausea and vomiting were severe.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00153641
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  • 19
    Electronic Resource
    Electronic Resource
    Human central nervous system pharmacology of pentamethylmelamine and its metabolites (1983)
    Springer
    Journal of neuro-oncology 1 (1983), S. 357-364 
    Details
    ISSN: 1573-7373
    Keywords: pentamethylmelamine ; intracerebral tumor ; brain ; cerebrospinal fluid
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Pentamethylmelamine (PMM) 80 mg/ m2 was administered IN. to 8 patients during surgical resection of intracerebral tumors. PMM concentrations in tumors were generally much higher than concurrent plasma concentrations, ranging from undetectable (〈 .01 μg/g) to as high as 4.47 μg/g and were much higher in malignant melanoma samples than in astrocytoma samples. PMM was barely detectable or undetectable in most samples of edematous brain tissue adjacent to intracerebral tumor and in temporalis muscle. The PMM metabolites tetramethylmelamine (TeMM), trimethylmelamine (TrMM), and dimethylmelamine (University of Texas Cancer Center M.D. Anderson Hospital and Tumor Institute, Houston, Texas, USADMM) were each detectable in tumor samples from one or two patients. Monomethylmelamine (MMM) was present in tumor samples from all except one patient. MMM was noted in samples of edematous brain tissue adjacent to tumor from 4 of 8 patients. It was the only PMM metabolite found in brain. TrMM, DMM, and MMM but not PMM, and TeMM were found in tumor cyst fluid from a patient with an intracerebral malignant melanoma. Two patients receiving therapeutic doses of PMM had biopsies taken of subcutaneous malignant melanoma deposits. PMM was undetectable in samples from one patient but reached high concentrations in the other patient. In both patients, MMM was the major metabolite. There was no indication that PMM penetrated into extracerebral tumors more readily than into intracerebral tumors. Cerebrospinal fluid (CSF) samples were obtained from one patient without neurological toxicity who received low doses of PMM and from 4 patients receiving high doses of PMM who had developed neurological toxicity. In each case, PMM was barely detectable or undetectable in the cerebrospinal fluid while TeMM was found in only one sample. TrMM was detectable in CSF from all 5 patients and DMM was found in CSF from 4 of the 5 patients. MMM was detected in CSF from 3 of the 4 patients with neurological toxicity but was undetectable in CSF from the patient without neurological toxicity. Thus, PMM penetrates readily into human intracerebral tumors but the concentrations attained may vary with the histology. PMM metabolites attained higher concentrations in brain and CSF than did PMM itself and may account for the drug's neurological toxicity.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00165719
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  • 20
    Electronic Resource
    Electronic Resource
    The pharmacologic fate of 2,5-diaziridinyl-3,6-bis(carboethoxyamino) 1,4-benzoquinone (AZQ NSC-182986) by intracarotid or intravenous administration in beagles (1983)
    Springer
    Journal of neuro-oncology 1 (1983), S. 219-224 
    Details
    ISSN: 1573-7373
    Keywords: AZQ ; dogs ; brain ; pharmacology ; intracarotid
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Beagle dogs received either intravenous (I.V.) or intracarotid (I.C.) 14C ring labelled 2,5-diaziridinyl-3,6-bis-(carboethoxyamino) 1,4-benzoquinone (AZQ) at a dose of 2 mg/ kg. Blood, urine and cerebrospinal fluid (CSF) samples were collected at intervals. At varying times, dogs from each group were sacrificed and histologic examination and drug determinations were performed on the major organs. By both routes of administration, the elimination of AZQ from plasma was biphasic with an initial half-life of 18 min and a terminal half-life of 26 hr. The apparent volume of distribution was 7.9 1/ kg and the total clearance was 3.5 ml/kg/h. The 96 hr cumulative urinary excretion of total 14C was 41% of the administered dose, including 4% as the unchanged drug. At 1, 48, and 96 hr after I. C. AZQ, drug concentrations in the brain tissue were twice those by the 1.V. route. High drug concentrations in the CSF were produced by both routes, although the CSF to plasma ratio was higher by I.C. than LV. In extracranial organs, tissue concentrations of AZQ were at least twice as high by LV. than by I.C. administration. No significant clinical or neurologic toxicity were noted when AZQ was given I.C. In the dog I.C. administration of AZQ seems to accelerate drug entry into the brain tissue.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00165606
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