Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0027497 (nausea)
 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Patients with newly diagnosed gliomas were treated with adoptive transfer of ex vivo activated T lymphocytes, derived from lymph nodes (LNs) draining autologous tumor vaccines, to determine the long-term toxicity of this treatment. Twelve consecutive patients were enrolled: 2 with grade II astrocytoma, 4 with anaplastic gliomas, and 6 with glioblastoma multiforme. Patients were injected intradermally with short-term cultured autologous irradiated tumor cells, admixed with granulocyte macrophage colony-stimulating factor, to stimulate draining LNs. The LN cells were activated with staphylococcal enterotoxin A for 48 h and then cultured in medium containing interleukin 2 for an additional 6-8 days and subsequently transferred i.v. to the patients. The number of cells obtained from the LNs ranged from 9 x 10(7) to 1.1 x 10(9), and the median cell proliferation was 41-fold. The dose of T cells infused ranged from 0.6 to 5.5 x 10(10) with a median of 1.1 x 10(10), the majority of which were CD 4+ (mean, 71%). The entire treatment was performed as outpatient therapy and was associated with a toxicity of grade 2 or less, consisting mainly of fever, nausea, and myalgias during the first 24 h. There were no indications of late adverse events from this treatment even among three patients with follow-up greater than 2 years post T cell transfer. Moreover, four patients demonstrated partial regression of residual tumor. This Phase I clinical trial of adoptive immunotherapy for patients with newly diagnosed malignant gliomas demonstrates feasibility, lack of long-term toxicity, and several objective clinical responses.
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PMID:T cell adoptive immunotherapy of newly diagnosed gliomas. 1087 70

A 29-year-old male patient with acute hepatitis B developed agranulocytosis about 2 months after the clinical onset of the hepatitis. Bone marrow examination showed hypercellularity and maturation arrest of myeloid leukogenesis at the stage of metamyelocyte. Anti-neutrophil antibody was negative. Since the patient did not show spontaneous recovery for 2 months, the patient received granulocyte-colony stimulating factor, but the therapy was a very short course because he had an elevation of temperature and nausea. Sixty-eight days after admission, he was started on lithium carbonate at a dose of 600 mg per day. About 3 weeks later, peripheral granulocyte counts had recovered to normal level.
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PMID:A case of agranulocytosis associated with severe acute hepatitis B. 1155 38

The main objectives of this study were to determine the feasibility of administering high doses of cyclophosphamide plus recombinant human granulocyte-colony stimulating factor (rhG-CSF) every 14-21 days to patients with follicular small cleaved cell lymphoma. For each patient, the treatment was not considered feasible if fewer than four cycles of cyclophosphamide chemotherapy could be administered on schedule (i.e. at least every 29 days) or (1) hospitalization of the patient for longer than three days was necessary for neutropenic fever (38 degrees C) or bacteriologically documented infection in > 50% of the cycles, or (2) grade > or = 2 hemorrhage in association with thrombocytopenia of grade > or = 3 severity occurred in > 50% of the cycles or (3) non-hematologic toxicity (excluding nausea/vomiting and alopecia) of grade > or = 3 occurred in > 50% of cycles. The goal was to have a treatment program feasible in 75% or more of the treated patients. The secondary objectives were to determine the toxicities, the complete and partial response rates, and the time to treatment failure (TTF). The trial also attempted to assess the effectiveness of this treatment program in eradicating Bcl-2 rearrangements by PCR, and to assess complete remission duration in relationship to PCR results in patients who respond to this chemotherapy program. Patients were required to have histologically documented non-Hodgkin's lymphoma of the subtypes follicular, predominantly small cleaved cell (IWF-B) or follicular mixed, (IWF-C). Patients were required to have Stage IV disease including histologic evidence of bone marrow involvement. Measurable disease was required and patients were also required to have one of the following risk factors: > or = 2 extranodal sites, node or nodal group > or = 5 cm. Submission of fresh bone marrow for molecular genetic studies for the presence of Bcl-2-Ig fusion DNA was mandatory in previously untreated patients. Patients had to be between 18 and physiologic age 55 years (carefully selected patients over age 55 years were also eligible), expected survival > 2 years, performance status 0-1, and have adequate renal, hepatic and bone marrow function, and a cardiac ejection fraction > or = 50%. Cyclophosphamide 4.5 g/m2 i.v. was given with mesna every 14 days with rhG-CSF support. Twenty-nine patients were accrued to this trial. The median follow-up time is 5.0 years, with a range of 2.5-6.7 years. The overall response rate was 75% (9 CRs 37.5%, 9PRs 37.5%). The median duration of survival is 5.53 years. The 1-year estimated probability of freedom from treatment failure was 50% and of survival at 1 year was 92%. No strong association was observed between TTF and age, symptomatic stage, histology performance status, number of extranodal sites or baseline Bcl-2 status. At 3 years the survival of all patients was 78% and failure free survival was 17%. 15 (62%) of the 24 eligible previously untreated patients met the criteria for feasibility specified in the protocol. The 95% CI for the feasibility rate is (44 and 82%). Twenty-two of the 24 (92%) previously untreated patients had specimens submitted for testing for Bcl-2 rearrangements. Thirteen of the 22 (59%) were found to have rearrangements at baseline. Post-treatment specimens were submitted for seven of the 13 patients. Four of the seven converted to Bcl-2 negative following treatment. Eight of 13 Bcl-2 positive patients (62%) had a clinical response to treatment. The 95% exact binomial CI for the total response rate in this subgroup is (28 and 88%). This study demonstrates that repetitive doses of cyclophosphamide at 4.5 g/m2 every two weeks with rhG-CSF support can be administered to selected younger patients with advanced follicular lymphoma with morphologic involvement of the bone marrow with acceptable non-hematologic toxicity.
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PMID:High dose cyclophosphamide plus recombinant human granulocyte-colony stimulating factor (rhG-CSF) in the treatment of follicular, low grade non-Hodgkin's lymphoma: CALGB 9150. 1191 6

A phase II study of a combination therapy with vinorelbine (Navelbine) plus cisplatin was performed using 27 patients with advanced non-small cell lung cancer, to evaluate the efficacy and safety of this therapy. Patients were treated, at 3-week intervals, with two or more courses of a regimen consisting of vinorelbine 25 mg/m2 (days 1, 8) and cisplatin 80 mg/m2 (day 1). The response rate was 48.1% (13/27) (95% confidence interval: 28.7-68.1%). The median number of treatment courses was 2.6. The major toxicity was hematological: 74% of patients had neutropenia of grade 3 or higher that subsided rapidly upon administration of a granulocyte-colony stimulating factor. Non-hematological toxicities were mild, of grade 2 or less: the main symptom was nausea/vomiting (62%), although constipation, eruption, anorexia, peripheral nerve disorders, diarrhea, fever, and other conditions were also observed. In conclusion, the high response rate and good tolerance to this combination therapy warrants further study.
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PMID:[Phase II study of combined Vinorelbine (Navelbine) plus cisplatin for advanced non-small cell lung cancer (an interim report)]. 1191 30

We report our clinical experience in autologous peripheral blood stem cells harvesting. A total of 40 patients with 112 apheresis procedures were analyzed, 88 with Cobe system and 24 with MCS3P system. Our results revealed that there was no significant difference in efficiency of CD34(+) cell harvesting between both apheresis systems, but the Cobe system had more nucleated cells collected and less red cell contaminated in the final PBSCs collections. The percentage of CD34(+) cells collected decreased significantly following the first day's harvesting (p = 0.026). There was a good correlation between the percentage of CD34(+) cells in PBSCs and colony forming units-granulocyte macrophage (CFU-GM) or burst forming unit-erythrocyte (BFU-E)(r = 0.909, p < 0.0001; r = 0.788, p < 0.0001, respectively). However, it was negatively correlated with the patient's age. The CD34(+) cells collected in patients with acute leukemias were also higher than those patients with other solid tumors. Ten cases (13%) with 15 apheresis procedures experienced side effects like numbness, nausea, fever, or headache etc. The Cobe system seemed to have higher frequency of side effects than that of MCS3P system (16% vs 4%). From our results, we concluded that both COBE and MCS3P system have similar efficiency and all patients could tolerate the apheresis procedures in peripheral blood stem cells harvesting. The CD34(+) cell can be used as a good parameter to estimate the amount of stem cells collected. The patient's age and disease pattern were significant factors influencing the CD34(+) stem cells collection in autologous peripheral blood stem cells harvesting.
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PMID:Autologous peripheral blood stem cells harvesting in Kaohsiung Medical University Hospital. 1216 92

The analog, rebeccamycin tartrate salt (NSC 655649, Cancer Therapy Evaluation Program, National Cancer Institute) has broad preclinical anti-neoplastic activity. Preliminary data from phase I study demonstrated antitumor activity in colorectal carcinoma. This phase II trial evaluates its efficacy in patients with minimally treated metastatic colorectal cancer. Eligibility included Karnofsky performance status > or = 70%, age > or = 18 years and bidimensionally measurable disease. Thirteen patients were treated with NSC 655649 at 500 mg/m2 by central venous catheter once every 3 weeks by bolus injection. Thirty-four cycles (median [range] 2 [1-6]) of therapy were administered. Twelve patients are eligible for response assessment. No major objective responses were seen using the RECIST criteria; however stable disease was observed in three patients with mean duration of 15 weeks. The median time to progression was 8 weeks. There was no toxic death. Four patients received only one cycle of treatment, and three had disease progression. Toxicities were tolerable and hematologic toxicity was the most common. The median (range) granulocyte and platelet nadir counts were 2043/microl (116-16,374/microl) and 276 x 10(3)/ microl (5-769), respectively. Non-hematologic toxicities were moderate, including generalized weakness/fatigue, nausea/vomiting, diarrhea and anorexia. One patient required dose reduction; three patients required dose delays. NSC 655649 at this dose and schedule is inactive against advanced previously minimally treated metastatic colorectal cancer and further study of this drug as a single agent in this disease using an every three-week schedule is not warranted.
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PMID:A phase II study of rebeccamycin analog NSC 655649 in patients with metastatic colorectal cancer. 1279 35

The purpose of this study was to assess the toxicity and efficacy of gemcitabine and docetaxel administered every other week as first-line therapy in metastatic breast cancer. Fifty-one patients with histologically confirmed metastatic breast cancer were enrolled. Patients received docetaxel 65 mg/m(2) followed by gemcitabine 2,500 mg/m(2), both on day 1 of a 14-day cycle, for 10 cycles without granulocyte-colony stimulating factor support. Thirty-five patients were evaluable for toxicity and 32 for efficacy. Median age was 65 years (range, 37 to 72 years), and median performance status was 90 (range, 60 to 100). The number of disease sites was 2 or > or =3 in 39% and 44% of patients, respectively, with visceral involvement in the liver and/or lung in 44% of patients. A total of 45% had received prior adjuvant chemotherapy. So far, 267 cycles have been administered. Twenty-five percent of the docetaxel and gemcitabine doses were reduced or delayed due primarily to neutropenia, giving a median dose intensity of 90% of the planned dose for both drugs. Grade 3/4 toxicities were mainly hematologic, with neutropenia in 46% of patients (two patients experienced neutropenic fever). Other toxicities were asthenia, diarrhea, transaminase elevation, and nausea. Overall response rate was 66% (four complete responses, 17 partial responses), with 22% of patients achieving stable disease. Responses were observed in all disease sites, including lung (60%) as well as liver (37.5%). In conclusion, preliminary evaluation from our phase II study shows that the combination of docetaxel and gemcitabine given every 2 weeks is a tolerable and highly active combination in patients with metastatic breast cancer. These data compare favorably with those obtained with other docetaxel schedules.
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PMID:Gemcitabine plus docetaxel administered every other week as first-line treatment of metastatic breast cancer: preliminary results from a phase II trial. 1519 28

We report a case of a woman with a metastatic liver tumor from gastric carcinoma, who has been successfully treated with concurrent proton beam therapy and systemic chemotherapy. A 76-year-old woman underwent distal gastrectomy with regional lymph node dissection for advanced gastric carcinoma on January 17, 2002. She received five courses of sequential chemotherapy with methotrexate-5-fluorouracil after the surgical resection. A metastatic liver tumor was detected in the caudate lobe of the liver by computed tomography at 6 months after the surgical resection. We employed concurrent proton beam therapy and systemic chemotherapy which consisted of 5-fluorouracil (250 mg/body per day, as a 24-h intravenous injection for 4 weeks) and low dose cisplatin (10 mg/body on days 1-5 every week for 4 weeks). Proton beam therapy targeting the metastatic liver tumor was performed in a daily fraction of 3 Gy, 5 days per week, with a total dose of 66 Gy over 30 days. The tumor disappeared 3 months after the treatment and no recurrence has been observed for 2 years after termination of the treatment. Throughout the entire course of treatment, the patient received injections of granulocyte stimulating factor subcutaneously for grade 3 leukopenia. She never complained of abdominal symptoms, such as epigastralgia, nausea or diarrhea. Liver failure related to proton irradiation has not been observed. This concurrent proton beam radiotherapy with systemic chemotherapy could be an effective treatment modality for metastatic liver tumor from gastric carcinoma.
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PMID:Concurrent proton beam radiotherapy and systemic chemotherapy for the metastatic liver tumor of gastric carcinoma: a case report. 1568 4

Active ulcerative colitis (UC) is frequently associated with infiltration of a large number of leukocytes into the bowel mucosa. Therefore, removal of activated circulating leukocytes by apheresis has the potential for improving UC. In Japan, since April 2000, leukocytapheresis using Adacolumn has been approved as the treatment for active UC by the Ministry of Health and Welfare. The Adacolumn is an extracorporeal leukocyte apheresis device filled with cellulose acetate beads, and selectively adsorbs granulocytes and monocytes/macrophages. To assess the safety and clinical efficacy of granulocyte and monocyte adsorptive apheresis (GMCAP) for UC, we reviewed 10 open trials of the use of GMCAP to treat UC. One apheresis session (session time, 60 min) per week for five consecutive weeks (a total of five apheresis sessions) has been a standard protocol. Several studies used modified protocols with two sessions per week, with 90-min session, or with a total of 10 apheresis sessions. Typical adverse reactions were dizziness, nausea, headache, flushing, and fever. No serious adverse effects were reported during and after GMCAP therapy, and almost all the patients could complete the treatment course. GMCAP is safe and well-tolerated. In the majority of patients, GMCAP therapy achieved clinical remission or improvement. GMCAP is a useful alternative therapy for patients with steroid-refractory or -dependent UC. GMCAP should have the potential to allow tapering the dose of steroids, and is useful for shortening the time to remission and avoiding re-administration of steroids at the time of relapse. Furthermore, GMCAP may have efficacy as the first-line therapy for steroid-naive patients or patients who have the first attack of UC. However, most of the previous studies were uncontrolled trials. To assess a definite efficacy of GMCAP, randomized, double-blind, sham-controlled trials are necessary. A serious problem with GMCAP is cost; a single session costs 145 000 ($1 300). However, if this treatment prevents hospital admission, re-administration of steroids and surgery, and improves a quality of life of the patients, GMCAP may prove to be cost-effective.
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PMID:Safety and clinical efficacy of granulocyte and monocyte adsorptive apheresis therapy for ulcerative colitis. 1648 63

Although leukocytapheresis (LCAP) has been reported to be effective for the treatment of various autoimmune disorders, little information has been published yet on the efficacy and safety of LCAP for the treatment of systemic-onset juvenile idiopathic arthritis (SOJIA). A pilot trial of LCAP was therefore conducted on two children with refractory SOJIA using a granulocyte apheresis filter packed with cellulose acetate beads in an attempt to control the disease flares. Following three to eight sessions of LCAP, the joint symptoms gradually resolved without any increase in the dose of corticosteroids. The procedure was associated with a decrease in the serum interleukin-6. No severe adverse effects were observed except for mild nausea. However, efficacy of LCAP sustained in a short time since both patients subsequently developed flares after 3 months of the treatment.
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PMID:Leukocytapheresis for the treatment of refractory systemic-onset juvenile idiopathic arthritis. 1656 93


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