ABSTRACT
PURPOSE: This was an open-label, dose-escalation trial of intratumoral administration of IL-4 Pseudomonas Exotoxin (NBI-3001) in patients with recurrent malignant glioma. PATIENTS AND METHODS: A total of 31 patients with histologically verified supratentorial grade 3 and 4 astrocytoma were studied. Of these, twenty-five patients were diagnosed with glioblastoma multiforme (GBM) while six were diagnosed with anaplastic astrocytoma (AA). Patients were over 18 years of age and had Karnofsky performance scores > or = 60. Patients were assigned to one of four dose groups in a dose-escalation fashion: 6 microg/ml x 40 ml, 9 microg/ml x 40 ml, 15 microg/ml x 40 ml, or 9 microg/ml x 100 ml of NBI-3001 administered intratumorally via stereotactically placed catheters. Patients were followed with serial MRI scans and clinical assessments every four weeks for the first 16 weeks and then every eight weeks until week 26. RESULTS: No drug-related systemic toxicity, as evident by lack of hematological or serum chemical changes, was apparent in any patients; treatment-related adverse effects were limited to the central nervous system. No deaths were attributable to treatment. Drug-related Grade 3 or 4 toxicity was seen in 39% of patients in all dose groups and 22% of patients at the maximum tolerated dose of 6 microg/ml x 40 ml. The overall median survival was 8.2 months with a median survival of 5.8 months for the GBM patients. Six-month survival was 52% and 48%, respectively. Gadolinium-enhanced magnetic resonance imaging of the brain showed areas of decreased signal intensity within the tumor consistent with tumor necrosis following treatment in many patients. CONCLUSIONS: NBI-3001 appears to have an acceptable safety and toxicity profile when administered intratumorally in patients with recurrent malignant glioma.
Subject(s)
Astrocytoma/drug therapy , Bacterial Toxins/administration & dosage , Exotoxins/administration & dosage , Glioblastoma/drug therapy , Immunotoxins/administration & dosage , Interleukin-4/administration & dosage , Neoplasm Recurrence, Local/drug therapy , Supratentorial Neoplasms/drug therapy , Adult , Aged , Astrocytoma/diagnosis , Bacterial Toxins/adverse effects , Chemotherapy, Adjuvant , Combined Modality Therapy , Dose-Response Relationship, Drug , Exotoxins/adverse effects , Female , Glioblastoma/diagnosis , Humans , Immunotoxins/adverse effects , Infusions, Intralesional , Interleukin-4/adverse effects , Magnetic Resonance Imaging , Male , Middle Aged , Neoplasm Recurrence, Local/diagnosis , Prospective Studies , Stereotaxic Techniques , Supratentorial Neoplasms/diagnosisSubject(s)
Brain Neoplasms/pathology , Brain Neoplasms/therapy , Genetic Therapy/methods , Glioblastoma/pathology , Glioblastoma/therapy , Neoplasm Recurrence, Local/pathology , Neoplasm Recurrence, Local/therapy , Adult , Aged , Animals , Brain Neoplasms/genetics , Brain Neoplasms/surgery , Female , Genetic Therapy/adverse effects , Glioblastoma/genetics , Glioblastoma/surgery , Humans , Magnetic Resonance Imaging/methods , Male , Mice , Middle Aged , Moloney murine leukemia virus/genetics , Neoplasm Recurrence, Local/genetics , Pilot Projects , Prospective Studies , Simplexvirus/enzymology , Simplexvirus/genetics , Thymidine Kinase/genetics , Thymidine Kinase/metabolism , Treatment OutcomeABSTRACT
Report on a case of a highly malignant solitary lymphoma of the cervix uteri in a 51-year-old patient. The only noticeable finding leading to the diagnosis was the pathological result of the routine cervical smear. Solitary malignant lymphomas of the cervix must be seen as systemic diseases. They should therefore be treated by local surgical intervention and consecutive systemical chemotherapy in an interdisciplinary conception.
Subject(s)
Lymphoma, Large-Cell, Immunoblastic/diagnosis , Lymphoma, Non-Hodgkin/diagnosis , Uterine Cervical Neoplasms/diagnosis , Cervix Uteri/pathology , Combined Modality Therapy , Female , Humans , Infant , Lymphoma, Large-Cell, Immunoblastic/pathology , Lymphoma, Large-Cell, Immunoblastic/therapy , Lymphoma, Non-Hodgkin/pathology , Lymphoma, Non-Hodgkin/therapy , Middle Aged , Uterine Cervical Neoplasms/pathology , Uterine Cervical Neoplasms/therapy , Vaginal SmearsABSTRACT
The oxazaphosphorine analog ifosfamide (IFO) has demonstrated an increased therapeutic index in a variety of solid tumors and hematologic malignancies compared with its parent compound cyclophosphamide. A fractionated dose schedule over 5 days as continuous infusion in combination with the uroprotective agent sodium-2-mercapto-ethane-sulfonate (mesna) is considered to provide an improved therapeutic/toxic ratio. Stability data of IFO demonstrate long-term stability for use in disposable infusion pumps as outpatient treatment. In all, 52 patients with various malignancies were entered in a feasibility study to receive outpatient continuous infusion of IFO. All patients were required to have a subcutaneous venous port system implanted. The following drug combinations were used: IFO as single agent, IFO/mitoxantrone, IFO/carboplatinum/etoposide, IFO/etoposide/MTX, IFO/epirubicin. Mitoxantrone and epirubicin were given as continuous infusion together with IFO. Starting dose of IFO was between 1.6-2.0 g/m2/day x 5 and was increased in absence of major hematologic or peripheral toxicity. Mesna was given in combination with IFO as continuous infusion at a dose of 50% of that calculated for IFO. No renal, bladder or central nervous system toxicity was observed. In 247 courses of outpatient continuous ifosfamide infusion only few technical complications due to improper handling were documented.
Subject(s)
Ambulatory Care , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Ifosfamide/administration & dosage , Neoplasms/drug therapy , Adult , Aged , Carboplatin/administration & dosage , Drug Administration Schedule , Drug Stability , Epirubicin/administration & dosage , Etoposide/administration & dosage , Feasibility Studies , Female , Humans , Infusion Pumps, Implantable , Infusions, Intravenous , Male , Mesna/administration & dosage , Middle Aged , Mitoxantrone/administration & dosageABSTRACT
The authors emphasize that the maxillo-facial surgeon or otorhinolaryngologist should: 1. take part in diagnosing and planning the therapy of poly-traumatic patients. 2. operate simultaneously when possible. 3. try to provide immediate maxillo-facial surgical and/or otorhinolaryngologic treatment because of the great importance of early treatment for longterm functional and aesthetic results.
Subject(s)
Craniocerebral Trauma/surgery , Orbital Fractures/surgery , Skull Fractures/surgery , Adult , Brain Injuries/diagnostic imaging , Brain Injuries/surgery , Craniocerebral Trauma/diagnostic imaging , Female , Humans , Male , Orbital Fractures/diagnostic imaging , RadiographyABSTRACT
In a study including a limited number of 33 patients with bacterial infections the use of doxycycline as a drip infusion of Vibramycin dry fill proved to have a good clinical effect. The bacteriological tests showed that 58% of the tetracycline-sensitive germs demonstrated before therapy had been eliminated and another 6% markedly reduced. Clinically very good or good results were achieved in 76% of the patients. Toleration was excellent in all cases.
Subject(s)
Doxycycline/therapeutic use , Adult , Dose-Response Relationship, Drug , Doxycycline/administration & dosage , Drug Evaluation , Drug Resistance, Microbial , Drug Tolerance , Female , Humans , Infusions, Parenteral , Kidney Failure, Chronic/drug therapy , Lung Diseases/drug therapy , Male , Middle AgedABSTRACT
The buildings of the clinics and institutions of the medical faculty in Münster which were planned in 1914 and completed in 1925 were enlarged considerably with numerous new buildings in the 1950's because of increasing specialisation in medicine. The university eye clinic built in 1925 was enlarged in 1970 by the addition of a bed wing and in 1975 by the new construction of the out patients department. In 1969 the foundation stone for the new central clinic with the four bed towers was laid. The eye clinic will not move into the new central clinic, because the old part of the present eye clinic was also completely renovated, besides the construction of both the additions. This description is complemented by conclusive data on the number and bed-use of the single clinics and on the cost of the new wing and the number of students.
