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The design of clinical protocols is an important factor in assuring patient accrual and compliance. This paper describes the methods used to assess the attributes of treatment and cancer control research protocols. Measures are presented for assessing three attributes considered important: relative advantage, complexity, and compatibility.
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The development of new bisphosphonates for clinical use requires congruence between the results of basic and clinical investigations. We have previously shown that this can be achieved with the use of an in vitro coculture mouse metacarpal resorption system sensitive to the activation of osteoclast precursors together with a clinical protocol in which the rate of decrease in urinary hydroxyproline excess with bisphosphonate treatment is assessed in patients with Paget's disease. In these studies bisphosphonates of known potencies were used. In the present study we have evaluated these approaches prospectively in the assessment of the antiresorptive potency of the new bisphosphonate (3-dimethylamino-1-hydroxypropylidene)-1,1-bisphosphonate (dimethyl-APD). A total of 42 patients with Paget's disease of bone received dimethyl-APD in doses predicted from the in vitro system. A total of 24 patients received the bisphosphonate intravenously (2, 4, and 8 mg/day) in groups of 8 patients each and 18 orally (100, 200, and 400 mg/day) in groups of 6 patients each for 10 days. Dimethyl-APD therapy was highly effective in inhibiting bone resorption. Urinary hydroxyproline excretion reached 30.9 +/- 5.6, 17.1 +/- 3.1, and 2.1 +/- 5.3% of initial excess after 10 days treatment with intravenous dimethyl-APD, 2, 4, and 8 mg/day, and 37.4 +/- 18, 10.4 +/- 8.5, and 13 +/- 4.1% with oral therapy, 100, 200, and 400 mg/day, respectively. Comparison of the antiresorptive potency of dimethyl-APD with that of APD showed that the former is roughly five times more potent, as predicted in the in vitro study.(ABSTRACT TRUNCATED AT 250 WORDS)
We have identified several general temporal-abstraction mechanisms needed for reasoning about time-stamped data, such as are needed in management of patients being treated on clinical protocols: simple temporal abstraction (a mechanism for abstracting several parameter values into one class), temporal inference (a mechanism for inferring sound logical conclusions over a single interval or two meeting intervals), and temporal interpolation (a mechanism for bridging non-meeting temporal intervals). Making explicit the knowledge required for temporal abstractions supports the acquisition of planning knowledge, the identification of clinical problems, and the formulation of clinical-management-plan revisions.
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We present a protocol for the management and follow up of facial palsies, in which, the clinical, diagnosis and therapeutical informations are obtained in order to evaluate the clinical assessment and pathology of this cranial nerve. We also present a computerized database system in order to develop statistical analysis and further studies on this peripheral nerve lesion.
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Circulating marker level determination in clinical practice requires an adequate strategy of application, in view of the particular features of the parameter related to the marker. The test result, which is usually expressed in terms of concentration, cannot be considered as an absolute value because every biochemical tumor indicator expresses an activity of the tumor which generally leads to increased levels of a "normal" substance in blood or biological liquids. Therefore, the result should be interpreted as a dynamic variation occurring in time, and should always be related to a previous reference value. This means that marker determination in clinical practice should be repeated periodically, both for the evaluation of tumor response to treatment and for the detection of recurrence after radical surgery. A single measurement at the time of disease presentation can characterize the tumor with regard to its capacity of producing the signal, and consequently regarding its extent and growth. These laboratory findings are of no value whatever if they are not integrated with all the other available clinical and instrumental data concerning the neoplasm; only then can they provide useful additional information. Also, all biological variables should be taken into account which may affect circulating marker levels independently of the history of the tumor such as sex, age, clearing organ function, race, alcohol and tobacco habits, concomitant diseases. These procedural protocols should be outlined and codified for each individual neoplasm since it is useless to work with scattered data which are not ordered in some kind of procedural logic.(ABSTRACT TRUNCATED AT 250 WORDS)
Clinical investigations utilizing Wellcome C. parvum in cancer therapy number more than one hundred in multiple institutions. Multiple diseases in various stages are being attacked by multi-modality therapy, making the role of immunotherapy very difficult to assess. Fundamental laboratory observations have suggested ways of weaving non-specific with specific immunotherapy, and these with chemotherapy and radiation to yield maximum therapeutic benefit. Current protocols include examples of the critical interactions as well as instructive information on dosing, timing and adjunctive symptomatic therapies. Several protocols will be reviewed, especially where promising clinical results are expected. Important differences between systemic and regional administration are observed.
Severe combined immunodeficiency (SCID) due to deficiency of the purine metabolic enzyme adenosine deaminase (ADA) is a fatal childhood immunodeficiency disease. Immune reconstitution by transplantation with HLA-identical bone marrow is the treatment of choice. For patients not candidates for bone marrow transplantation, we propose to attempt immune reconstitution by using infusions of autologous T lymphocytes expanded in tissue culture and genetically corrected by insertion of a normal ADA gene using retroviral-mediated gene transfer. The vector is LASN, in which the human ADA gene is promoted by the LTR while the NeoR gene is driven by the SV40 early gene promoter. The packaging line is PA317. The protocol is designed to have two parts. In Part 1, autologous gene-corrected T lymphocytes would be infused repeatedly in low numbers in order to build an immune repertoire of T cells and also to obtain information as to how long gene corrected T cells survive in vivo. In Part 2A, the gene-corrected T cells would be selected in G418 and/or 2'deoxyadenosine and reinfused into the patient at monthly intervals for approximately 6 months. The goals would be essentially the same as in Part 1. In Part 2B, the number of gene-corrected T cells would be escalated in half-log increments to the predicted therapeutic level (probably around 1 x 10(9)/kg). 1-3 x 10(9)/kg gene-corrected cells would be infused several times and the patients would be monitored in order to determine if significant clinical improvement has occurred.