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At least 145 records · Page 8Linked to original sources
PubMed1988

Guidelines for clinical protocols for chronic lymphocytic leukemia: recommendations of the National Cancer Institute-sponsored working group.

The National Cancer Institute (NCI)-sponsored Chronic Lymphocytic Leukemia (CLL) Working Group was convened to develop a set of standardized eligibility, response, and toxicity criteria for clinical trials. We recognized the previous efforts in 1967 (published again in 1973 as the report of the Chronic Leukemia-Myeloma Task Force [1] and 1978 of Cancer and Leukemia Group B (CALGB) [2]). We have used these reports for guidance during the current effort. Several noteworthy developments in the past few years have made it necessary to modify the previous guidelines. First, the diagnostic criteria for CLL and its clinical staging have been developed and well defined. Second, although staging systems facilitated entry of comparable and relatively homogeneous groups of patients in clinical trials, the definitions of response (CR) and partial response (PR) were not uniformly adopted from the previous guidelines in the clinical trials (Tables IA, IB); therefore, comparisons of results obtained in different studies became difficult. Third, there has been an improvement in our understanding of the immunology and biology of CLL. Finally, we are witnessing the emergence of several chemotherapy agents that promise impressive activity in CLL (e.g., 2'-deoxycoformycin [3], fludarabine monophosphate [4, 5]), and thereby offer the potential for improving survival time in this disease. To best identify regimens worthy of continued pursuit in large comparative trials, standardized guidelines for evaluation are essential. A number of laboratory investigations are also presented for which scientific interest is high yet relevance remains to be determined; thus, they are presented as companion studies to the clinical trials. This mechanism allows for flexibility in the testing of these questions and for additional ideas in the future without requiring modification of an entire treatment protocol. The following guidelines were developed to be used as a form of standardization for clinical trials, incorporating current technologies, yet remaining relevant to the general hematology/oncology community. Based on the membership of the Working Group, it is expected that these guidelines will serve as the criteria for most clinical trials in the near future.

Antineoplastic Agents↗
PubMed1995

[Clinical protocols in treatment of prostatic carcinoma in Europe. The role of EORTC and other organizations].

In the last few years the EORTC has conducted multiple clinical studies on the therapy of prostate cancer. In most cases with incidental unifocal prostate cancer, no therapy is necessary, as the disease is rarely progressive or the cause of death. Current EORTC studies are evaluating the timing of hormone therapy, as it is still unknown whether therapy should be started at the time of diagnosis or when the patient becomes symptomatic. Different hormone therapies are useful for locally progressive prostate cancer and as effective than radiotherapy in the case of progression and survival. The preliminary results of a current study on total androgen blockade for 3 months before radical prostatectomy show a positive effect for some of the patients with a T2 carcinoma. Inconclusive results in studies on total androgen blockade versus orchiectomy in metastasising prostate cancer have lead to a meta-analysis of 22 studies by the EORTC. This only showed a trend towards better survival time and longer interval till progression with total androgen blockade but the group of patients with small volume metastatic disease benefit greatly from this treatment. The importance of estrogen therapy and the treatment with high dose non steroidal antiandrogens as well as the use of intermittent hormonal therapy in progressive disease will have to be assessed in future studies. Chemotherapy is not very effective due to its low response rate and its short lived effect.

Androgen Antagonists↗
PubMed1986

Comparison of clinical protocols through the mathematical results analysis of survival curves.

In an effort to establish a survival curve model which could help to evaluate adjuvant therapy, two equations were presented to approximate the various clinical curves. These curves usually show three different segments, describing high-risk, intermediate-risk and low-risk groups. The percentage of patients and the annual mortality in each risk group can be calculated from the coefficients of the equation. The present study analysed the survival curves of variously treated uterine cancer and stomach cancer after resection on the one hand, and of adjuvant therapy of breast cancer, malignant melanoma and acute lymphoid leukaemia on the other hand. This method of analysis should be useful for understanding and comparison of curves of phase III trials.

Antineoplastic Agents↗
PubMedDate not supplied

Immunogene therapy of recurrent glioblastoma multiforme with a liposomally encapsulated replication-incompetent Semliki forest virus vector carrying the human interleukin-12 gene--a phase I/II clinical protocol.

Glioblastoma multiforme (GBM) is an incurable brain tumor resistant to standard treatment modalities such as surgery, radiation, and chemotherapy. Since recurrent GBM tends to develop predominantly within the infiltrative rim surrounding the primary tumor focus, novel therapy strategies need in addition to focal tumor destruction to target this somewhat diffuse area. This is a phase I/II clinical study in adult patients with recurrent GBM which is aimed at evaluating biological safety, maximum tolerated dose, and antitumor efficacy of a genetically modified replication-disabled Semliki forest virus vector (SFV) carrying the human interleukin 12 (IL-12) gene and encapsulated in cationic liposomes (LSFV-IL12). The vector will be administered in doses of 1 x 10(7)-1 x 10(9) infectious particles by continuous intratumoral infusion, thus exploiting the advantages of convection-enhanced drug delivery in the brain. The present protocol is also designed to investigate systemic and local immune response and to identify factors predicting tumor response to LSFV-IL12 therapy, such as volume of extracellular space of the tumor, volume of contrast enhancing lesion, and immune status of the patients. SFV, an insect alphavirus, infects mitotic and non-mitotic cells and triggers apoptosis in tumor cells within 48-72 h. Preclinical work with the LSFV-IL12 vector in breast and prostate cancer animal models demonstrated its biosafety and some antitumor efficacy. An ongoing phase I clinical study in patients with melanoma and renal cell carcinoma seems also to confirm the biosafety of intravenously administered vectors. This protocol will be the first study of SFV-IL12 therapy of human recurrent GBM.

Adult↗
PubMedDate not supplied

Synergistic therapy of breast cancer with Y-90-chimeric L6 and paclitaxel in the xenografted mouse model: development of a clinical protocol.

BACKGROUND: Paclitaxel (Taxol) has demonstrated synergistic enhancement of radioimmunotherapy (RIT) of breast cancer with Y-90 labeled antibody ChL6, in the xenografted mouse model. To determine the optimal sequence and timing of RIT and Taxol for a prospective clinical trial, efficacy and dosimetry in mice, and dosimetry in patients receiving RIT alone, were examined. MATERIALS AND METHODS: Mice bearing human breast cancer xenografts (HBT 3477) received i.v. Y-90-DOTA-peptide-ChL6 (260 microCi), and i.p. Taxol (300 or 600 micrograms) 72, 48, or 24 hours prior to RIT, or 6, 24, 48, or 72 hours after RIT. RESULTS: Taxol after RIT resulted in cure, CR, or PR of all mice (70/70 tumors) and demonstrated greater therapeutic enhancement (p = 0.001) than Taxol before RIT. Mice receiving 600 micrograms Taxol 48 hours after RIT achieved 88% cure (7/8 tumors). In mice, 57% and 42% of the radiation dose to tumor and marrow, respectively, was delivered from 48-336 hours after RIT; in patients receiving 90Y-DOTA-peptide-ChL6, the corresponding values were 56% and 22%. CONCLUSIONS: Taxol given approximately 48 hours after RIT provides coincident peak deposition of Taxol and Y-90 in tumor, and no Taxol in the marrow during the major radiation dose to marrow, resulting in therapeutic enhancement without observable additive toxicity. A clinical trial of low dose Taxol given after RIT to patients with metastatic breast cancer is planned.

Adenocarcinoma↗
PubMed2004

Integrating sensory and motor mapping in a comprehensive MEG protocol: clinical validity and replicability.

Considerable evidence supports the idea of magnetoencephalography (MEG) being a valuable noninvasive tool for presurgical mapping of sensory and motor functions. In this study, we test the validity and replicability of a new experimental paradigm for simultaneous sensory and motor mapping using MEG recordings. This comprehensive sensorimotor protocol (CSSMP), where external mechanic stimulation serves as a cue for voluntary movements, allows the recording of sensory and motor cortical responses during a single activation task. The stability and replicability of MEG-derived recordings during this paradigm were tested in a group of eight neurologically normal volunteers and six patients with perirolandic lesions. We found that a common sensorimotor cortical network, engaging sensory (S1, S2) and motor (M1) areas, was reliably activated in all subjects and patients and that the results remained exceptionally stable over time. Additionally, the clinical validity of the MEG-derived maps of activation was tested through intraoperative electrocortical stimulation mapping in the group of patients. The MEG-derived anatomical maps for specific sensory (S1) and motor (M1) responses were verified, by direct cortical mapping, and confirmed with the patient's surgical outcome. The results of this validation study show that the so-called CSSMP is a reliable and reproducible method for assessing simultaneously sensory and motor areas. This method minimizes methodological problems and improves our knowledge of the spatiotemporal organization of the sensorimotor cortical network and helps to optimize the surgical management of patients with perirolandic lesions.

Adult↗
PubMed1994

[Clinical protocols concerned with disorders of fatty acid beta oxidation].

Inborn defects in fatty acid oxidation are a newly described group of diseases affecting infants and child. This disorder frequently masquerades as Reye's syndrome or sudden infant death syndrome. The known defects, now totaling 11, share many clinical similarities. Clinical manifestations include episodes of coma and hypoglycemia that are induced by fasting, or chronic, progressive muscle weakness and cardiomyopathy. Affected patients are often free of symptoms between episodes. A characteristic organic aciduria or enzyme activity in cultured skin fibroblasts permit diagnosis. Because of high mortality and morbidity rates, early diagnosis is desirable. treatment for survivors siblings is simple and is associated with avoidance of prolonged fasting. Systemic screening of the general population should be initiated to identify those affected and start treatment before they become ill.

Child↗
PubMed2003

Replacement of missing teeth with fiber-reinforced composite FPDs: clinical protocol.

The concept of minimally invasive preparation protocols has resulted in reduced loss of critical tooth structures and maintenance of optimal strength, form, and aesthetics. While various treatment options have been described for single-tooth replacement, fiber-reinforced composite (FRC) fixed partial dentures (FPDs) provide a viable treatment alternative with proven mechanical properties, aesthetics, and function. This article presents several clinical scenarios in which minimally invasive adhesive FRC FPDs are provided to deliver enhanced predictability, strength, and durability.

Aged↗
PubMed1995

Postoperative vaginal cuff irradiation using high dose rate remote afterloading: a phase II clinical protocol.

PURPOSE: In September 1989, a postoperative Phase II high dose rate (HDR) brachytherapy protocol was started for International Federation of Gynecology and Obstetrics (FIGO) Stage I endometrial adenocarcinoma. This review reports the overall survival, local control, and complication rates for the initial 63 patients treated in this Phase II study. METHODS AND MATERIALS: High dose rate brachytherapy was delivered using an Iridium-192 HDR remote afterloader. Sixty-three patients were entered into the Phase II protocol, each receiving two vaginal cuff treatments 1 week apart (range 4-12 days) with vaginal ovoids (diameter 2.0-3.0 cm). No patient received adjuvant external beam radiation. A dose of 32.4 Gy in two fractions was prescribed to the ovoid surface in 63 patients. The first three patients treated at our institution received 15, 16.2, and 29 Gy, respectively, to determine acute effects. RESULTS: At a median follow-up of 1.6 years (range 0.75-4.3 years) no patient has developed a vaginal cuff recurrence. One regional recurrence (1.6%) occurred at 1.2 years at the pelvic side wall. This patient is alive and without evidence of disease 7 months after completion of salvage irradiation, which resulted in the only vaginal stenosis (1.6%). Fourteen patients (22%) experienced vaginal apex fibrosis by physical exam, which was clinically symptomatic in four patients. Two patients reported stress incontinence; however, these symptoms were noted prior to their HDR therapy. One patient died 2.4 years after HDR therapy due to cardiovascular disease without evidence of cancer at autopsy. CONCLUSION: Preliminary results of our phase II HDR vaginal cuff protocol for postoperative FIGO Stage IA, Grade 3 or Stage IB, Grade 1-2 patients demonstrate that 32.4 Gy in two fractions is well tolerated by the vaginal cuff mucosa. Local control appears comparable to our prior experience and others with low dose rate (LDR) brachytherapy. Additional patient accrual and further follow-up will better determine the late morbidity, local control, and overall survival of these patients.

Adult↗
PubMed2000

[Fewer x-rays while maintaining quality of clinical care using clinical protocols for physical diagnosis of ankle injuries].

OBJECTIVE: To determine whether it is possible to decrease the number of X-rays in acute ankle injury while keeping the health care constant, using a scoring system. DESIGN: Prospective. METHOD: Patients presenting in the emergency department of the University Hospital Utrecht (AZU), the Netherlands, over a one-year period of time with acute ankle injuries were subjected to a thorough physical examination based on a scoring system developed at Leiden University Hospital. The score was calculated and X-ray examination was indicated when this score was > or = 8 points. Radiological investigation or telephone interviews six weeks after injury achieved verification of the clinically relevant ankle fractures. Specificity and sensitivity were calculated from every possible cut-off point and drawn in a 'receiver operating characteristics' (ROC) curve. RESULTS: Of the 514 patients included 81 patients had a score of 8 or higher and 24 of them had a clinically relevant fracture. In 34 patients an ankle X-ray was made although their score was < 8 points. The positive and negative predictive values of the system were 30% (95% confidence interval (95% CI): 20-41) and 99% (95% CI: 97-100) respectively. The score yielded an area under the ROC curve of 91% (95% CI: 84-98). A cut-off point of 8 led to a reduction of X-rays by 60% (using the 'Ottawa ankle rules' the decrease in this population would have been 28%). On the other hand, 5 clinically relevant fractures were missed. CONCLUSION: Radiological examination in patients wit acute ankle complaints was reduced while health care remained almost constant. In the AZU, a decision was made for a major reduction in X-rays while accepting that some fractures would be missed.

Adult↗
PubMedDate not supplied

Clinical protocols herald new era of nursing documentation.

Documenting care tends to be a time-consuming process and information is often replicated. This paper describes how documentation was changed in one acute hospital trust to reflect UKCC guidelines and for use by all disciplines. Evaluation suggests that less time is spent writing records and that those records are more complete.

Aged↗
PubMed2005

Emerging concepts in glioma biology: implications for clinical protocols and rational treatment strategies.

Glioblastoma multiforme (GBM), the most common primary central nervous system neoplasm, is a complex, heterogeneous disease. The recent identification of stem cells in murine tumor xenografts that were capable of recapitulating the tumor phenotype adds a new dimension of complexity to the already challenging treatment of patients with GBMs. Although specific cellular and genetic changes are commonly associated with GBM, the mechanism by which those changes occur may have a significant impact on treatment outcome. Of the many bioinformatics techniques developed in recent years, gene expression profiling has become a commonly used research tool for investigating tumor characteristics, and the development of rationally targeted molecular therapies has also accelerated following the initial success of specifically designed inhibitors in the treatment of malignancies. Despite these advances in research techniques and targeted molecular therapies, however, limited clinical impact has been achieved in the treatment of infiltrative malignancies such as GBMs. Thus, further extension in survival of patients with GBMs may require use of multiple analyses of tumors to develop tailored therapies that reflect the inter- and intratumoral heterogeneity of this disease. In this review, the authors briefly consider the potential use of expression profiling combined with mutation analysis in the development of treatment modalities to address the heterogeneity of this complex tumor phenotype.

Animals↗
PubMed2002

[Dose-reduced conditioning before allogeneic stem cell transplantation: principles, clinical protocols and preliminary results].

BACKGROUND AND OBJECTIVE: In the treatment of leukemia by stem cell transplantation, the immunological effects of allogeneic T-lymphocytes presumably play a greater part than high-dosage total-body irradiation (TBI) and chemotherapy. Using this immunological effect, attempts are currently being made to reduce the dosage of pre-treatment that is toxic to stem cell, such as TBI, thereby making transplantation available for a larger group of patients at high risk for transplantation. This study presents preliminary results of three current studies of this approach. PATIENTS AND METHODS: Elderly patients with chronic myeloid leukemia (CML) have an increased transplantation risk. They were conditioned with TBI that was reduced stepwise (n = 27). Patients with advanced and refractory myeloid leukemia were treated with chemotherapy and dose-reduced TBI (FLAMSA protocol; n = 54). In patients with multiple myeloma, autologous transplantation with high-dose chemotherapy preceded allogeneic transplantation possible after dose-reduced conditioning (Tandem protocol; n = 6). RESULTS: All three protocols of TBI gave results that were not worse than those of previous studies. Relapse ocurred not more frequently in patients with CML. In patients with high-risk AML the FLAMSA protocol gave better results. Autologous-allogeneic tandem transplantation was well tolerated and led to a good response in all patients. CONCLUSION: Allogeneic transplantation after dose-reduced conditioning opens up new possibilities with respect to widening indications for transplantation and improving results in hematological diseases with previously unsatisfactory treatment.

Adolescent↗
PubMed2004

Clinical protocol. Administration of a replication-deficient adeno-associated virus gene transfer vector expressing the human CLN2 cDNA to the brain of children with late infantile neuronal ceroid lipofuscinosis.

Late infantile neuronal ceroid lipofuscinosis (LINCL) is a fatal childhood neurodegenerative lysosomal storage disease with no known therapy. There are estimated to be 200 to 300 children in the United States at any one time with the disease. LINCL is a genetic disease resulting from a deficiency of tripeptidyl peptidase I (TPP-I), a proteolytic enzyme encoded by CLN2, the gene that is mutated in individuals with LINCL. The subjects are chronically ill, with a progressive CNS disorder that invariably results in death, typically by age 8 to 12 years. The strategy of this clinical study is based on the concept that persistent expression in the CNS of the normal CLN2 cDNA with production of sufficient amounts of TPP-I should prevent further loss of neurons, and hence limit disease progression. To assess this concept, an adeno-associated virus vector (AAV2CUh-CLN2) will be used to transfer to and express the human CLN2 cDNA in the brain of children with LINCL. The vector consists of the AAV2 capsid enclosing the 4278-base single-stranded genome consisting of the two inverted terminal repeats of AAV serotype 2 and an expression cassette composed of the human cytomegalovirus (CMV) enhancer, the chicken beta-actin promoter/splice donor and 5' end of the intron, the 3' end of the rabbit P-globin intron and splice acceptor, the human CLN2 cDNA with an optimized Kozak translation initiation signal, and the polyadenylation/transcription stop codon from rabbit 3-globin. The proposed study will include 10 individuals and will be divided into two parts. Group A, to be studied first, will include four individuals with the severe form of the disease. Group B of the trial will include six individuals with a moderate form of the disease. After direct intracranial administration of the vector, there will be neurological assessment based on the LINCL clinical rating scale and magnetic resonance imaging/magnetic resonance spectroscopy assessment of the brain in regions of vector administration. The data generated will help evaluate two hypotheses: (1) that it is safe to carry out direct intracranial administration of the AAV2cuhCLN2 vector to the CNS of individuals with LINCL, and (2) that administration of the AAV2cuhCLN2 vector will slow down or halt the progression of the disease in the central nervous system.

Adolescent↗