Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0015672 (fatigue)
 51,768 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Twenty consecutive metastatic renal cell carcinoma patients were treated with a combination of recombinant alpha-2a interferon (18 X 10(6) U three times weekly) and vinblastine (0.1 mg/kg every 3 weeks). Two patients (10% response rate; 95% confidence limits 1.23-31.7%) achieved partial response and 11 (55%) stable disease. Toxicity was significant but always acceptable: most frequently, patients complained of fever and flu-like symptoms (18 of 19 patients), fatigue (18 of 19 patients), worsening in performance status (15 of 19 patients), and anorexia (15 of 19). The combination of recombinant alpha-2a interferon and vinblastine is active in renal cell carcinoma.
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PMID:Recombinant alpha-2a interferon plus vinblastine in the treatment of metastatic renal cell carcinoma. 249 41

Human lymphoblastoid interferon (IFN-alpha MOR-22; OIF) was administered to forty-two patients suffering from renal cell carcinoma. Twenty-six patients with metastatic lesions or primary tumor were treated in a clinical trial with either MOR-22 alone or combination of MOR-22 and UFT (or FT-207). The efficacy was assessed in ten of twenty patients who had received MOR-22 alone for more than eight weeks, but objective response was not observed. The efficacy was done in eight of fourteen patients with MOR-22 and UFT (or FT-207) in combination. Complete response was achieved in one, and partial response in two, with an objective response rate of 37.5%. But the difference was no statistically significant in the survival rate of each therapy. In evaluable twenty patients with MOR-22 prophylactically, there was only one case who had occurred lung metastases with a refractory rate of 8.3%. Forty-one patients were examined for side effects to drugs. The main side effects were fever, anorexia, general fatigue, hematologic toxicities, and hepatic dysfunction in both therapy. These side effects occurred with more increased frequency in combination therapy of UFT (or FT-207) compared to MOR-22 alone.
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PMID:[Combination therapy of renal cell carcinoma with interferon-alpha and UFT (or FT-207)]. 250 5

Twenty-five patients with disseminated cancer (nine with renal cell carcinoma, five with melanoma, three with Hodgkin's lymphoma and chronic myelocytic leukemia [CML], two with soft tissue sarcoma, one each with large-cell lymphoma, breast cancer, and colon cancer), 13 males and 12 females, aged 25 to 68, were treated with recombinant human interleukin-2 (rIL2) by continuous infusion and adoptive transfer of autologous lymphocytes activated in vitro with IL2. Patients underwent leukapheresis on days 1, 8, 15, and 22 of the treatment. Cells, bulk activated for 20 hours in serum-free culture medium with 1,000 U IL2/mL in transfusion transfer packs as culture vessels, were transfused the following day. The infusion of IL2 by continuous infusion for six days started immediately after each adoptive transfer for 4 weekly courses. The dose of IL2 was escalated weekly in each patient; starting doses of IL2 were also escalated in subsequent cohorts of patients until maximally tolerated doses were reached. Nine patients had objective tumor regressions (three with renal cell cancer, two with Hodgkin's lymphoma, and one each with melanoma, sarcoma, breast, and colon cancer). Six responses were partial, two were minor, and one was mixed. Responding patients were maintained with IL2 by continuous infusion for six days every 6 to 8 weeks, without adoptive cell transfer. The median duration of responses was 16 weeks (3 to 60 + weeks). Tumor regression was related to the dose of IL2 (greater than or equal to 3.4 x 10(6) U/m2/d for six days) and to the in vivo lymphoproliferative effects of the lymphokine, but not to the total number of cells adoptively transferred. Side effects of treatment were transient and quickly reversible. Renal, hepatic dysfunction, and dyspnea were directly related to the dose of IL2 and to lymphocytosis. Other toxicities were mild hypotension with mild fluid retention, oral mucositis, anemia, thrombocytopenia, fever, and fatigue.
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PMID:Recombinant interleukin-2 by continuous infusion and adoptive transfer of recombinant interleukin-2-activated cells in patients with advanced cancer. 266 33

A total of 66 patients with advanced renal cell cancer received a combination of recombinant interferon alpha-2a (18 times 10(6) units subcutaneously 3 times weekly) and vinblastine (0.1 mg. per kg. intravenously every 3 weeks). Four patients were ineligible and 6 were inevaluable for response but evaluable for toxicity. There were no complete and 9 partial responses among the 56 evaluable patients, for a response rate of 16 per cent. Median duration of response was 26 weeks, with a range of 8 to 50 weeks. Responses were observed predominantly in patients with lung and soft tissue metastases. Patients who had undergone nephrectomy did not show a better response rate than those who had not. Almost all patients had a flu-like syndrome, fatigue and anorexia. Other side effects included leukopenia, nausea, vomiting, liver function disturbances and neurotoxicity. Most of the side effects were World Health Organization grade 1 or 2; no grade 4 toxicity was observed. Antibodies against interferon developed in 6 patients during the course of treatment. However, there was no relationship between the appearance of antibodies and disease progression. The combination of recombinant interferon alpha-2a and vinblastine has modest but definite activity in patients with advanced renal cell carcinoma, although the role of vinblastine is unclear.
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PMID:Phase II study of recombinant interferon alpha-2a and vinblastine in advanced renal cell carcinoma. 274 39

Based on a preclinical study demonstrating the synergistic antitumor effect of recombinant interleukin 2 (rIL-2) and beta-interferon (IFN-beta) on mouse tumors and previous results of a phase I study of rIL-2, a phase I study of combination therapy with human rIL-2 and IFN-beta was conducted in 26 patients with advanced malignancy. Patients were given rIL-2 by 24-h continuous i.v. infusion and IFN-beta by 2-h i.v. infusion for 5 days each week for 4 weeks. The common side-effects were fever, malaise, chills, appetite loss, and diarrhea. Leukocytosis and eosinophilia were observed in 56% and 69% of the patients, respectively. Transient leukopenia and thrombocytopenia were also observed in some patients. Dose-limiting manifestations were intolerable fatigue and liver dysfunction, and it was concluded that the maximum tolerated doses of rIL-2 combined with IFN-beta were 1.1 x 10(6) U/m2/day for rIL-2 and 6.0 x 10(6) IU/m2/day for IFN-beta. No patients achieved complete and partial response to therapy in this study. One patient with pulmonary metastasis from pharyngeal cancer showed a minor response. Natural killer (NK) and lymphokine-activated killer (LAK) activities increased during the 5 days of treatment and decreased during the 2-day intermission. The percentage of IL-2 receptor-positive cells increased markedly until Day 12, and gradually decreased thereafter. The percentage of OKT 4-positive cells and the OKT 4/OKT 8 ratio increased. In contrast, the percentage of Leu 7- or Leu 11-positive cells decreased over the 4-week treatment. A phase II study of this combination therapy is ongoing against head and neck cancer, and renal cell carcinoma.
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PMID:Phase I study of combination therapy with interleukin 2 and beta-interferon in patients with advanced malignancy. 278 85

We performed clinical analysis of 12 patients with renal cell carcinomas associated with tumor thrombosis in the inferior vena cava. Eleven cases were men, and one was a woman; their ages range from 48 to 76 years old with a mean of 58 years. Nine tumors were observed on the right side, the other 3 tumors were observed on the left side. In five cases, the distant metastases of the disease were noticed at the first visiting to our hospital. Lung metastases were found in five and bone or liver in each one. Chief complaints were macroscopic hematuria in 8 cases (67%), and were weight loss or general fatigue. The symptoms of obstruction of the inferior vena cava, such as venous dilatation of abdominal wall, edema of lower extremities and varicocele of the testes, were seen in 6 cases. The level of the tumor thrombosis was preoperatively determined by CT, echography, cavography or MRI. The level was near the right atrium in one, near the hepatic vein in 8 and near the renal vein in 3, although there was no case extending into the right atrium. Transperitoneal nephrectomy and thrombectomy in the inferior vena cava were performed in 9 cases. Surgery could not be performed in the other 3 patients of their poor general condition or severe heart disease. One patient died because of massive hemorrhage during the operation. The other complications were transient renal failure in 3 cases and postoperative bleeding in one case. In 4 patients without distant metastases or regional lymph nodes metastasis, two died of multiple metastasis of renal cell carcinomas and diabetic coma. The other two cases are alive without disease for 4 and 40 months after operation. For renal cell carcinoma extending into the inferior vena cava without metastasis, nephrectomy and thrombectomy should be performed using the extracorporeal circulation.
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PMID:[Clinical analysis of renal cell carcinoma with extension into the inferior vena cava]. 279 51

A phase I-II study of human recombinant interferon gamma (rIFN-gamma) was conducted in patients with various advanced cancer refractory to standard chemotherapies. In the phase I study, seven patients received 14 courses of escalating doses ranging from 2 X 10(6)U/m2 to 64 X 10(6)U/m2 by 1-hour intravenous infusion for 5 consecutive days. The toxicities were high fever with chills, anorexia, occasional nausea and vomiting, elevation of serum GOT, and dose-related leukopenia and neurotoxic symptoms such as heavy fatigue with somnolence or lethargy, both of which were reversible. The pharmacokinetics showed that the peak levels of serum rIFN-gamma activity were dose-related but decreased rapidly to below measurable levels within 6 hours after infusion in patients receiving less than 12 X 10(6)U/m2. Considering these data, the dosage of rIFN-gamma 6 X 10(6) U/m2 by daily intramuscular injection for more than 4 weeks was selected for the early phase II study. There was no partial response out of 11 evaluable patients but a stable condition was observed in 2 cases of renal cell carcinoma and one case each of breast cancer and ovarian cancer. All toxicities seen were similar to those observed in the phase I study, but no tachyphylaxis developed with continued dosage. The antitumor effect of rIFN-gamma remains to be evaluated in a further study employing higher doses.
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PMID:[Phase I-II study of recombinant interferon gamma]. 298 59

A phase II study of recombinant human interferon gamma (rHuIFN-gamma) administered intravenously and intramuscularly was carried out in 84 patients with advanced renal cell carcinoma with the cooperation of 18 institutions throughout Japan. The eligibility of the patients and evaluation of the responses were undertaken according to the general criteria proposed by Drs. Koyama and Saito. Out of 84 cases entered in this phase II study, 62 patients were evaluable for antitumor effects. In the case of continuous administration of 8-12 X 10(6) U/m2/day interferon for 4 weeks, 32 patients were evaluable. The response rate was 6.3%. In the case of intermittent therapy of 40 X 10(6) U/m2/day interferon for 8 weeks, six out of 30 patients (20%) were evaluable as responders. Among them, one patient showed a complete response, all patients tolerated this type of interferon well. Major adverse effects were fever (86.8%), anorexia (67.1%), fatigue (53.9%) and leukopenia (42.1%). No life-threatening toxicities were found. The results of this study showed that rHuIFN-gamma had antitumor activity against renal cell carcinoma.
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PMID:[Phase II study of recombinant human interferon gamma (S-6810) in renal cell carcinoma. Urological Cooperative Study Group of Recombinant Human Interferon Gamma (S-6810)]. 310 7

Seventeen institutions in Japan evaluated the antitumor activity of recombinant human interferon gamma (S-6810) as a new modality for advanced renal cell carcinoma. The response rate for 32 evaluable patients who received continuous daily administration of 8 X 10(6) U/m2 to 12 X 10(6) U/m2 of interferon for 4 weeks was 9.4%. Six of 30 patients (20%) were demonstrated responders in the case of the intermittent administration of 40 X 10(6) U/m2 of interferon on each of days 1 to 5, 15 to 19, 29, 31, 33, 43, 45, and 47 over an 8-week period. One of the responders achieved a complete response (CR). The patients tolerated this dose of interferon gamma well. Sites that responded to treatment were the lungs, lymph nodes, and brain. Major adverse effects included fever (86.8% of patients), anorexia (67.1%), fatigue (53.9%), and leukopenia (42.1%). No life-threatening side effects appeared. High doses of recombinant human interferon gamma have an antitumor activity against renal cell carcinoma.
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PMID:Phase II study of recombinant human interferon gamma (S-6810) on renal cell carcinoma. Summary of two collaborative studies. Recombinant Human Interferon Gamma (S-6810) Research Group on Renal Cell Carcinoma. 311 77

A phase I and a phase II study of recombinant gamma-interferon (S 6810) were conducted on a cooperative basis involving 11 and 57 institutions, respectively. In the phase I study, a total of 40 courses were administered to 31 patients. High fever exceeding 38 degrees C with chills was observed in approximately 80%. Other toxicities were fatigue (50%), gastrointestinal symptoms (30-40%), changes in hepatic enzymes, and hematological toxicities (20-30%). Dose-limiting factors were judged to be hypotension, leucopenia and CNS toxicity. Since the optimal dose for the phase II study was considered to be 5 X 10(6) U/m2 by daily chronic schedule, a further study was conducted using this dose. Response rates were as follows: 14.3% (renal cell cancer), 11.8% (multiple myeloma) 40.0% (chronic lymphocytic leukemia), 16.7% (non-Hodgkin lymphoma), and 67% (mycosis fungoides). Complete response was obtained in one case each of renal cell cancer, malignant lymphoma and mycosis fungoides. Moreover, intermittent high-dose gamma-interferon against renal cell cancer induced a response rate of 21.4%, significantly higher than the 8.6% obtained by continuous administration. Local injection against cutaneous malignancies resulted in a 55.3% response rate. Anti-viral effect against herpes zoster infection was also preliminarily evaluated. Among 4 cases, 3 responded subjectively well to local injection of gamma-interferon, which is a hopeful result, although a randomized trial is still needed.
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PMID:[Gamma interferon therapy of cancer patients]. 313 83


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